D-0320-2021 Class II Terminated
FDA drug recall D-0320-2021 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on March 15, 2021 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated June 6, 2023). Affected quantity: 91,211 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- April 14, 2021
- Initiation Date
- March 15, 2021
- Termination Date
- June 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 91,211 syringes
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
NJ
Code Information
Lots JKU1212A, JKU1503A, JKU1504A, JKU1505A, JKU1506A, Exp 03/2021; JKU3313A & JKU3314A, Exp 08/2021.