Fulvestrant Injection
FDA Recall NDC 68462-317
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 Fulvestrant (NDC 68462-317). A significant event, classified as Class II, was initiated on Aug 27, 2021 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "Lack of Assurance of Sterility"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of Assurance of Sterility
Aug 27, 2021
Sep 29, 2021
28658 cartons
Recall Profile & Regulatory Data
Event ID
88591
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Oct 04, 2023
Product Description
Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32
Batch or Lot Expiration Information
Lot# Lots: 30200014 Exp. 04/30/2022; 30200015 Exp. 05/31/2022; 30200015 Exp. 05/31/2022; 30200016 Exp. 05/31/2022; 30200036 Exp. 09/30/2022; 30200038 Exp. 09/30/2022; 30200039 Exp. 09/30/2022; 30200040 Exp. 09/30/2022; 30210001 Exp. 12/31/2022; 30210002 Exp. 12/31/2022; 30210003 Exp. 01/31/2023; 30210004 Exp. 01/31/2023; 30210005 Exp. 01/31/2023; 30210006 Exp. 01/31/2023; 30210014 Exp. 02/28/2023; 30210022 Exp. 02/28/2023; 30210028 Exp. 02/28/2023; 30210029 Exp. 02/28/2023; 30210030 Exp. 02/28/2023; 30210031 Exp. 02/28/2023
Affected Packages Involved in this Recall
68462-317-40Product
68462-317-32Product
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.
