FDA Drugs recall ·
Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL… recall
- Recall number
- D-0218-2025
- Date
- (initiated January 10, 2025)
- Company / brand
- Teva Pharmaceuticals USA, Inc
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 34,636 cartons
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025
Distribution
Product was distributed nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0218-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.