1000 active records
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Subpotent Drug
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Failed tablet specifications.
Failed Tablet/Capsule Specifications
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Microbial Contamination of Sterile Products: Affected lots have been deemed non-sterile following discovery of a contaminant (Paenibacillus phoenicis), which may pose a potential infection risk to vulnerable groups.
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
CGMP Deviations
CGMP Deviations
Defective container; inadequately sealed blister packaging.
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
CGMP Deviations
Lack of Assurance of Sterility
CGMP Deviations
CGMP Deviations
Stability Data Does Not Support Expiry Date.
Stability Data Does Not Support Expiry Date.
CGMP Deviations
CGMP Deviations
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
Lack of Assurance of Sterility
CGMP Deviations
CGMP Deviations
Stability Data Does Not Support Expiry Date.
CGMP Deviations
CGMP Deviations
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations
Failed Dissolution Specifications
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Failed Dissolution Specifications
Presence of Particulate Matter: Due to production issues
Failed Dissolution Specifications
CGMP Deviations
Failed Dissolution Specifications
CGMP Deviations
CGMP Deviations
CGMP Deviations
Failed Dissolution Specifications
CGMP Deviations
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
Presence of Foreign substance - potential presence of metal particulate matter
cGMP deviations
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Defective container: Multiple customer complaints received for card seal defects observed on the subject lots. Customers reported card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Lack of Assurance of Sterility
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Lack of Assurance of Sterility
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Tablets/Capsules Imprinted with Wrong ID
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Lack of Assurance of Sterility
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Defective Delivery System: Missing or duplicated needles within the injection kit
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
cGMP deviations
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
Presence of Foreign substance - potential presence of metal particulate matter
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
Presence of Foreign Tablets/Capsules
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
CGMP Deviations: product found to contain lead.
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Failed Impurities/Degradation Specifications
Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
Failed Disintegration Specifications: above the time expected.
Failed PH Specifications
Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsules. Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients.
Presence of Foreign Substance
Subpotent Drug
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
cGMP deviations.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Presence of Particulate Matter.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Presence of particulate matter - Glass like particles.
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
cGMP Deviations
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
cGMP Deviations
Out of specification for dissolution.
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Presence of particulate matter - Glass like particles.
Presence of particulate matter - Glass like particles.
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Presence of Particulate Matter: Hair was found in a prefilled syringe
Presence of Particulate Matter: Hair was found in a prefilled syringe
Lack of Assurance of Sterlity
Presence of particulate matter: potential presence of metal particulates in the product.
Presence of particulate matter: potential presence of metal particulates in the product.
Presence of Foreign Tablets/Capsules
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Subpotent product:out of specification assay results observed during long term stability testing.
Defective container: cracked/broken cartridges
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
Subpotent product:out of specification assay results observed during long term stability testing.
Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
Subpotent product:out of specification assay results observed during long term stability testing.
Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
Failed stability specifications: Out of specification for hardness test
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Defective container - seal not adhering to bottles
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Failed stability specifications: Out of specification for hardness test
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cross Contamination with Other Products
Incorrect Product Formulation
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
cGMP deviations
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
cGMP deviations
CGMP Deviations
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
cGMP deviations
cGMP deviations
cGMP deviations
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
cGMP deviations
Defective Container - A defect in the side-seal which allows leakage of product.
cGMP deviations
Failed Stability Specifications: Observed OOS results: eg results for colour index
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
CGMP Deviations
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Failed Dissolution Specifications
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Subpotent Drug
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Subpotent drug; Clavulanate Potassium component
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Lack of Assurance of Sterility
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: Potential presence of metal particulate matter
Labeling: Not Elsewhere Classified
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Lack of Assurance of Sterility
Lack of Assurance of Sterility.
Lack of Assurance of Sterility
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Defective Container
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Lack of Assurance of Sterility
CGMP Deviations: Potential presence of metal particulate matter
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
CGMP Deviations: Potential presence of metal particulate matter
Lack of Assurance of Sterility
Lack of Assurance of Sterility: Potential for flexible container leaks.
CGMP Deviations: Potential presence of metal particulate matter
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Product Mix-up
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: Potential presence of metal particulate matter
Presence of Particulate Matter
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
CGMP Deviations: Potential presence of metal particulate matter
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Failed Tablet/Capsule Specifications
Failed Dissolution Specifications
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Tablet/Capsules Imprinted with Wrong ID
Marketed Without an Approved NDA/ANDA
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Subpotent Drug
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Tablet/Capsules Imprinted with Wrong ID
Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Presence of Particulate Matter: Particulate matter identified as glass
Lack of Assurance of Sterility.
Failed Dissolution Specifications
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
Discoloration
Labeling: Incorrect or Missing Lot and/or Exp Date
Failed Dissolution Specifications
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Lack of Assurance of Sterility:
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Failed Dissolution Specifications
Failed Dissolution Specifications
Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Failed Content Uniformity Specifications
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Lack of Assurance of Sterility
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Microbial Contamination of Sterile Products: elevated endotoxin levels
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of assurance of sterility.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Failed Dissolution Specifications.
CGMP Deviations: Market complaints received for gritty texture (grainy)
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Cross Contamination with Other Products.
Cross Contamination with Other Products.
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Failed Impurities/Degradation Specifications:
Failed Impurities/Degradation Specifications:
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Failed Impurities/Degradation Specifications:
Failed Impurities/Degradation Specifications:
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Subpotent drug
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Failed Impurities/Degradation Specifications:
cGMP Deviations
Lack of Assurance of Sterility
Failed Impurity/Degradation Specifications
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Superpotent drug
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Failed Impurity/Degradation Specifications
cGMP deviations: Temperature excursion during transportation.
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Defective Container: broken or leaking bottles.
Temperature Abuse
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Presence of a foreign substance.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Presence of a foreign substance.
cGMP violations
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Subpotent Drug
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Presence of Particulate Matter.
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Subpotent Drug
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Subpotent Drug
Presence of Particulate Matter
Subpotent Drug
Subpotent Drug
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Discoloration
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Lack of Assurance of Sterility.
Lack of Assurance of Sterility.
Discoloration
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Lack of Assurance of Sterility.
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Failed Dissolution Specifications: low dissolution results
Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Subpotent drug
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Lack of Processing Controls.
Lack of Processing Controls.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Lack of Processing Controls.
Lack of Processing Controls.
Lack of Processing Controls.
Presence of foreign substance: identified as aluminum.
Lack of Processing Controls.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Lack of Processing Controls.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Lack of Processing Controls.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Lack of Processing Controls.
Lack of Processing Controls.
Lack of Processing Controls.
Lack of Processing Controls.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Lack of Processing Controls.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
CGMP Deviations; particulates identified during visual inspection
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
CGMP Deviations; particulates identified during visual inspection
Failed Dissolution Specifications.
Sub-Potent Drug: Subpotent assay results during stability testing.
CGMP Deviations; potential temperature excursions due to transit delays
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Sub-Potent Drug: Subpotent assay results during stability testing.
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
CGMP Deviations; potential temperature excursions due to transit delays
CGMP Deviations; potential temperature excursions due to transit delays
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Subpotent Drug: Assay below the approved specification
Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Subpotent Drug: Assay below the approved specification
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
CGMP Deviations
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
CGMP Deviations
Subpotent Drug: Assay below the approved specification
CGMP Deviations
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Subpotent Drug: Assay below the approved specification
cGMP deviations
cGMP deviations
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
cGMP deviations
cGMP deviations
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Failed Impurity/Degradation Specifications
Failed Impurities/Degradation Specifications.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Defective container; blister packaging inadequately sealed.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Failed Impurity/Degradation Specifications
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Failed Impurities/Degradation Specifications.
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Defective container; blister packaging inadequately sealed.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Presence of foreign tablets/capsules.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Marketed Without an Approved NDA/ANDA
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Discoloration; discolored solution from cracked vials
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Failed Dissolution Specifications
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Presence of a foreign substance: black hair found embedded in tablet.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
cGMP deviations
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
OOS results reported for the Dissolution (by UV) test.
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Failed Impurities/Degradation Specifications
Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
CGMP Deviations
Defective delivery system
CGMP Deviations
CGMP Deviations
CGMP Deviations
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
cGMP deviations
CGMP Deviations
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
CGMP Deviations
CGMP Deviations
CGMP Deviations
cGMP deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
CGMP Deviations
cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.
Lack of Assurance of Sterility
CGMP Deviations
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
cGMP deviations and lack of assurance of sterility.
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Presence of Particulate Matter
Presence of Particulate Matter: Glass particles were found in pellet vials.
cGMP deviations and lack of assurance of sterility.
Presence of Particulate Matter: Glass particles were found in pellet vials.
Lack of Assurance of Sterility
cGMP deviations and lack of assurance of sterility.
Presence of Particulate Matter: Glass particles were found in pellet vials.
cGMP deviations and lack of assurance of sterility.
Presence of Particulate Matter: Glass particles were found in pellet vials.
cGMP deviations and lack of assurance of sterility.
Presence of Particulate Matter: Glass particles were found in pellet vials.
Subpotent
Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.
Subpotent
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
cGMP Deviations
Subpotent
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Subpotent
CGMP Deviations
Lack of Assurance of Sterility: Leaking/damaged syringes.
cGMP deviations
cGMP deviations
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
CGMP Deviations
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
cGMP deviations
cGMP deviations
cGMP deviations
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Lack of Assurance of Sterility: Leaking/damaged syringes.
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Lack of Assurance of Sterility: Leaking/damaged syringes.
Lack of Assurance of Sterility: Leaking/damaged syringes.
CGMP Deviations
Lack of Assurance of Sterility: Leaking/damaged syringes.
cGMP deviations
CGMP Deviations
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Lack of Assurance of Sterility: Media fill with bacterial contamination
CGMP Deviations
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
CGMP Deviations
CGMP Deviations
Cross Contamination
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
Lack of Assurance of Sterility: Media fill with bacterial contamination
CGMP Deviations
CGMP Deviations
Chemical contamination: Presence of benzene
CGMP Deviations
Lack of Assurance of Sterility: Media fill with bacterial contamination
CGMP Deviations
CGMP Deviations
CGMP Deviations
Presence of Particulate Matter
Lack of Assurance of Sterility: Media fill with bacterial contamination
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
Cross Contamination
CGMP Deviations
Lack of Assurance of Sterility: Media fill with bacterial contamination
CGMP Deviations
Chemical contamination: Presence of benzene
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
Failed dissolution specifications: lower than specifications
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Presence of Foreign Tablets/Capsules.
Lack of Assurance of Sterility
Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Lack of Assurance of Sterility
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Lack of Assurance of Sterility
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Presence of foreign substance: Presence of Benzene.
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Lack of Assurance of Sterility
Presence of foreign substance: Presence of Benzene.
Chemical contamination: presence of benzene
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Failed Dissolution Specifications - low dissolution results
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Super-Potent Drug: Out of specification potency results were obtained.
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Subpotent Drug
Subpotent Drug
Chemical contamination: presence of benzene
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Super-Potent Drug: Out of specification potency results were obtained.
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Failed Dissolution Specifications
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
CGMP Deviations
CGMP Deviations
Presence of foreign tablets/capsules
Chemical Contamination: Presence of benzene.
Chemical Contamination
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
CGMP Deviations
Presence of Particulate Matter
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Chemical Contamination: Presence of benzene
CGMP Deviations
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
Chemical Contamination
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
CGMP Deviations
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Failed Dissolution Specifications
Failed Impurities/Degradation Specifications
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Failed Impurities/Degradation Specifications
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Lack of Assurance of Sterility: due to a quality control process deviation. During an internal quality assurance review, an Acceptable Quality Limit (AQL) inspection was not conducted on a statistically sound number of samples. This may result in the inability to assure that the impacted products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess and may lead to products of unacceptable quality.
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Lack of Assurance of Sterility
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
Presence of Particulate Matter.
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Out of Specification for Dissolution
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Superpotent; sodium benzoate preservative
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Failed Dissolution Specifications.
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
CGMP Deviations: lack of adequate release testing.
CGMP Deviations; product intended for quarantine was inadvertently distributed
Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Failed Dissolution Specifications:
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Presence of Foreign Tablets/Capsules
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Non-Sterility
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Failed Stability Specifications
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
CGMP Deviations
Presence of Foreign Tablets/Capsules
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
LABELING: LABEL MIX-UP
Crystallization
Failed Dissolution Specifications
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Failed Impurities/Degradation Specifications
Crystallization
LABELING: LABEL MIX-UP
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Discoloration
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Lack of Sterility Assurance
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
CGMP deviations: out of specifications for assay
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Failed Impurities/Degradation Specifications
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Lack of Sterility Assurance
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Subpotent and Superpotent Drug
Subpotent and Superpotent Drug
Superpotent Drug and Subpotent Drug: potency failures obtained
Subpotent and Superpotent Drug
Subpotent and Superpotent Drug
Subpotent and Superpotent Drug
CGMP Deviations: Released product should have been rejected.
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Subpotent and Superpotent Drug
Failed Impurities/Degradation Specifications
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
cGMP Deviations: Temperature excursion
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
cGMP Deviations: Out of specification results for micro in hand soap products.
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Labeling: Label Mix-Up
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Presence of Particulate Matter: Potential for glass delamination from the vials.
Subpotent drug
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Presence of Particulate Matter: Potential for glass delamination from the vials.
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
cGMP Deviations: Out of specification results for micro in hand soap products.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
CGMP Deviations: Inconsistency in the water systems.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Labeling: Not Elsewhere Classified - Wrong NDC number
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
cGMP Deviations: Out of specification results for micro in hand soap products.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit