Recalls / Class II
Class IID-0320-2021
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.
- Affected lot / code info
- Lots JKU1212A, JKU1503A, JKU1504A, JKU1505A, JKU1506A, Exp 03/2021; JKU3313A & JKU3314A, Exp 08/2021.
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 91,211 syringes
- Distribution pattern
- NJ
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-04-02
- Posted by FDA
- 2021-04-14
- Terminated
- 2023-06-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0320-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.