WhichRecall
Class IIReported 2025-02-12

Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC 63459-910-12; (c) 1 syringe in 1 CARTON, NDC 63459-910-17 without safety guard and blister, Rx Only, Manufactured by: UAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel.

Recalled by Teva Pharmaceuticals USA, Inc

Reason for Recall

Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit

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Recall Number
D-0218-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-01-10
Reported
2025-02-12
Distribution
Product was distributed nationwide.
Code Info
Lot # (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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