Granix Injection, Solution
FDA Recall NDC 63459-920
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Granix (NDC 63459-920). A significant event, classified as Class II, was initiated on Jan 10, 2025 by Cephalon, Llc. The reported reason for this action was: "Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
January 2025 Class II Recall: Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Recall Number
Class II Ongoing
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Jan 10, 2025
Feb 12, 2025
34,636 cartons
Recall Profile & Regulatory Data
Event ID
96115
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide.
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.
Batch or Lot Expiration Information
Lot# (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025
Affected Packages Involved in this Recall
63459-910-01Product
63459-910-12Product
63459-910-11Product
63459-910-15Product
63459-910-18Product
63459-910-17Product
63459-910-36Product
63459-912-01Product
63459-912-12Product
63459-912-11Product
63459-912-15Product
63459-912-18Product
63459-912-17Product
63459-912-36Product
63459-918-53Product
63459-918-59Product
63459-920-53Product
63459-920-59Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
