FDA Recall Ongoing Historical recordClass II
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-274-01
- Reason
- Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
- Published
- December 17, 2025
- Distribution
- FL, MA, MI & OH
