Recalls / Class II
Class IID-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.
- Brand name
- Granix
- Generic name
- Tbo-filgrastim
- Active ingredient
- Filgrastim
- Route
- Subcutaneous
- NDCs
- 63459-910, 63459-912, 63459-918, 63459-920
- FDA application
- BLA125294
- Affected lot / code info
- Lot # (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025
Why it was recalled
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc
- Manufacturer
- Cephalon, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 34,636 cartons
- Distribution pattern
- Product was distributed nationwide.
Timeline
- Recall initiated
- 2025-01-10
- FDA classified
- 2025-02-04
- Posted by FDA
- 2025-02-12
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0218-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.