Data Composite

Recall D-0220-2026

US Class II Ongoing · initiated 2025-11-13

Recalling firm

Lupin Pharmaceuticals Inc., FL

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

Reason for recall

Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.

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