PlainRecordsFDA · Drug recall
Ganirelix Acetate Injection…
- Date
- April 14, 2021
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): 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)
- Status
- Terminated
- Filed by
- Sun Pharmaceutical Industries Inc
- 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.
- Reason
- Failed Impurities/Degradation Specifications
- Distribution pattern
- NJ
- Quantity
- 91,211 syringes
- Codes and lots
- Lots JKU1212A, JKU1503A, JKU1504A, JKU1505A, JKU1506A, Exp 03/2021; JKU3313A & JKU3314A, Exp 08/2021.
- Recall started
- March 15, 2021
- Recall number
- D-0320-2021
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement report, recall number D-0320-2021. The agency record governs; check it and the company before acting.