Status
Ongoing
Drug Enforcement D-0218-2025
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Classification
Class II
Report Date
February 12, 2025
Termination Date
—
Product Information
- 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.
- 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
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed nationwide.
Location & Firm
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Address
-
400 Interpace Pkwy Bldg A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0218-2025
- Event ID
- 96115
- Recall initiation date
- January 10, 2025
- Center classification date
- February 4, 2025
- Code info
- Lot # (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025
- More code info
- —