GRANIX (TBO-FILGRASTIM)
Wed Feb 12 2025
1 of 57
Summary
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Product Description
| Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
|---|---|---|---|
| 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. | Cephalon, LLC | Product was distributed nationwide. | 34,636 cartons |