January 2025 FDA Recall Granix by Teva Pharmaceuticals Usa, Inc
D-0218-2025 - Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc on January 10, 2025 for the product Granix. The FDA reported the reason for recall as failed stability specifications - 12-month stability test result for one of the known peptides is below the specification limit. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0218-2025
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
01-10-2025
02-12-2025
34,636 cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025
