July 2022 FDA Recall Fulvestrant by Zydus Pharmaceuticals (usa) Inc (D-1351-2022 - Failed Impurities/Degradation Specifications)

This Class II drug recall was voluntarily initiated by Zydus Pharmaceuticals (usa) Inc on July 15, 2022 for the product Fulvestrant. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1351-2022

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
07-15-2022
Reported
08-24-2022
Quantity
1116 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90618
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-18-2024
Product Description About Product Description
Full technical description of the product.
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

70710-1688-2 Fulvestrant
70710-1688-8 Fulvestrant