Fulvestrant Injection, Solution
FDA Recall NDC 70710-1688
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 70710-1688). A significant event, classified as Class II, was initiated on Jul 15, 2022 by Zydus Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
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
Failed Impurities/Degradation Specifications
Jul 15, 2022
Aug 24, 2022
1116 boxes
Recall Profile & Regulatory Data
Event ID
90618
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Jun 18, 2024
Product Description
Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila Healthcare Limited, Ahmadabad, India, Distributed by: Zydus Pharmaceuticals (USA ) Inc.m Pennington, NJ 08534, NDC 70710-1688-8.
Batch or Lot Expiration Information
Lot# B200076; Exp 31 JAN 2024
Affected Packages Involved in this Recall
70710-1688-2Product
70710-1688-8Product
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.
