Class II
Ongoing
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.
- Company
- Teva Pharmaceuticals Usa, Inc
- Recall Initiated
- January 10, 2025
- Posted
- February 12, 2025
- Recall Number
- D-0218-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 34,636 cartons
- Firm Location
- Parsippany, NJ, United States
Reason for Recall
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Distribution
Product was distributed nationwide.
Lot / Code Info
Lot # (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025
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