March 2021 FDA Recall Drug by Sun Pharmaceutical Industries Inc
D-0320-2021 - Failed Impurities/Degradation Specifications

This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on March 15, 2021 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in NJ and the recall is currently terminated.

Recall Number: D-0320-2021

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
03-15-2021
Reported
04-14-2021
Quantity
91,211 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87545
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.
SUN PHARMACEUTICAL INDUSTRIES 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.
NJ
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA, Manufactured by: Sun Pharmaceutical Industries Ltd, Halol, Gujarat, India Made in India, NDC 55566-1000-1.

Batch or Lot Expiration Information

Lot# Lots JKU1212A, JKU1503A, JKU1504A, JKU1505A, JKU1506A, Exp 03/2021; JKU3313A & JKU3314A, Exp 08/2021.