27 recalls on record
Failed tablet specifications.
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.
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
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.
Failed Dissolution 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.
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.
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
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
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Failed Dissolution Specifications:
Presence of Foreign Tablets/Capsules
Presence of Foreign Tablets/Capsules
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 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 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 the recommended interim limit