Reported Apr 14, 2021 · Terminated
Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals,…
Sun Pharmaceutical Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
- Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only
- DistributorFerring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA
- Manufactured bySun Pharmaceutical Industries Ltd, Halol, Gujarat, India Made in India, NDC 55566-1000-1
- Lot codes and dates
Lots JKU1212AJKU1503AJKU1504AJKU1505AJKU1506AExp 03/2021JKU3313A & JKU3314AExp 08/2021
- Amount recalled
- 91,211 syringes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Failed Impurities/Degradation Specifications
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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