Drug product
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.
D-0218-2025
Product summary
- Event
- Event 96115
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 34,636 cartons
- Official record key
drug-enforcement:D-0218-2025
Official wording
Reason: Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Code information: Lot # (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025
Distribution pattern: Product was distributed nationwide.
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications