Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, N
Summary
The FDA issued a Class II for Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, by Teva Pharmaceuticals USA, Inc. Reason: Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit.
Details
Source
Drug Recall
External ID
D-0218-2025
Action Date
2025-02-12
Status
Ongoing
Category
drug
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/Code Info: Lot # (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025
Quantity Affected: 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
Distribution
Product was distributed nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-10
Company
Parsippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 46 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Teva Pharmaceuticals USA, Inc has 50 FDA actions in our database, including 50 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Teva Pharmaceuticals USA, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Teva Pharmaceuticals USA, Inc have FDA actions?
Teva Pharmaceuticals USA, Inc has 50 FDA actions in our database, including 50 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0218-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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