FDARecalled Dec 17, 2025 · #D-0220-2026
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, ...
Hazard
Class II — temporary health risk
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Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity. Classification: Class II Distribution: FL, MA, MI & OH
Product details
- Product
- 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
- Type
- Drugs
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Model numbers
- WB00006
- UPCs
- —