FDA-Drug2025-12-17Class 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
Lupin Pharmaceuticals Inc.
Hazard
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Sold states
FL, MA, MI & OH
Affected count
32736 vials
Manufactured in
5801 Pelican Bay Blvd, Suite 500, Naples, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0220-2026Don't want to check this manually?
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