FDA Recall D-0218-2025

Teva Pharmaceuticals USA, Inc · Parsippany, NJ

Class II Ongoing 489 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: Lot # (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025

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 record

Recall number: D-0218-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Product was distributed nationwide.
Recall initiated: 2025-01-10
Classified by FDA Center: 2025-02-04
FDA published: 2025-02-12
Recalling firm: Teva Pharmaceuticals USA, Inc
Firm location: Parsippany, NJ

Drug identification

Brand name(s): GRANIX
Generic name(s): TBO-FILGRASTIM
Manufacturer(s): Cephalon, LLC
NDC(s): 63459-910, 63459-912, 63459-918, 63459-920
Route(s): SUBCUTANEOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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