Why it was recalled
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
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.
Lot numbers, UPCs & expiration codes
Lot # (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025
Where it was sold
Product was distributed nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0218-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 10, 2025
- FDA report date
- Feb 12, 2025
- Quantity
- 34,636 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc
Original FDA data
Every field from FDA enforcement report D-0218-2025, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96115
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot # (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025
- Postal code
- 07054-1120
- Report date
- Feb 12, 2025
- Product type
- Drugs
- Recall number
- D-0218-2025
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Product was distributed nationwide.
- Recall initiation date
- Jan 10, 2025
- Initial firm notification
- Letter
- Center classification date
- Feb 4, 2025