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Lupin Pharmaceuticals Inc.: Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin

DrugsSource: FDA (drug) · Date: 2025-12-17

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Lupin Pharmaceuticals Inc.
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 / hazard
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Classification
Class II
Status
Ongoing
Distribution / sold at
FL, MA, MI & OH
Recall initiated
2025-11-13
Code info
Lot #: WB00006, Exp 12/31/2026
Product quantity
32736 vials
Voluntary mandated
Voluntary: Firm initiated
City
Naples
State
FL
Country
United States
Event id
97990
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