FDAFDA · Food and drugs·Recall number D-0218-2025
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.
Published February 12, 2025 · Recall initiated: January 10, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- GRANIX
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Distributor
- Product was distributed nationwide.
- Lot
- Lot # (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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