Teva Pharmaceuticals USA, Inc recalls Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, N
Recalled February 12, 2025 · FDA recall D-0218-2025 · Teva Pharmaceuticals USA
Hazard
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit · FDA Class II
Units
34,636 cartons
Sold at
Product was distributed nationwide.
Description
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
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.
Manufacturer(s)
Teva Pharmaceuticals USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →