FDA Drug Class II — Moderate

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

Hazard

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

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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, Man
Brand
Lupin Pharmaceuticals Inc.
UPC
Lot #: WB00006, Exp 12/31/2026

Units Affected

32736 vials

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