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.
This recall is currently active, issued February 12, 2025. It was issued by Teva Pharmaceuticals Usa, Inc.
- 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
- Official Source
- View on FDA website ↗
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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