FDAHealthJanuary 10, 2025
Teva Pharmaceuticals USA, Inc — 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
⚠️ Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 10, 2025
Product was distributed nationwide.
What's affected?
- 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.
- Brand
- GRANIX
- Lot code
- (a)
Additional details
Lot # (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 34,636 cartons.
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