Teva Pharmaceuticals USA, Inc: Drug Recall
Recall #D-0218-2025 · 01/10/2025
Class II: Risk
Recall Details
- Recall Number
- D-0218-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Teva Pharmaceuticals USA, Inc
- Status
- Ongoing
- Date Initiated
- 01/10/2025
- Location
- Parsippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34,636 cartons
Reason for Recall
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Product Description
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.
Distribution Pattern
Product was distributed nationwide.
Other Recalls by Teva Pharmaceuticals USA, Inc
- Class III: Low Risk 11/07/2025
- Class II: Risk 10/13/2025
- Class II: Risk 10/07/2025
- Class II: Risk 10/07/2025
- Class II: Risk 10/07/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.