Drug recall D-0218-2025
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.
Reason for recall
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Lots and codes
Lot # (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Inc, Parsippany, NJ
- Quantity
- 34,636 cartons
- Distribution
- Product was distributed nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 10, 2025
Related products
- Granix – drug information
- NDC 63459-912 Granix · Filgrastim 480 ug/.8mL · Cephalon, LLC
- NDC 63459-910 Granix · Filgrastim 300 ug/.5mL · Cephalon, LLC
- NDC 63459-918 Granix · Filgrastim 300 ug/mL · Cephalon, LLC
- NDC 63459-920 Granix · Filgrastim 480 ug/1.6mL · Cephalon, LLC