Drug 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.
D-0320-2021
Product summary
- Event
- Event 87545
- Status
- Terminated
- Classification
- Class II
- Quantity
- 91,211 syringes
- Official record key
drug-enforcement:D-0320-2021
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lots JKU1212A, JKU1503A, JKU1504A, JKU1505A, JKU1506A, Exp 03/2021; JKU3313A & JKU3314A, Exp 08/2021.
Distribution pattern: NJ
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications