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
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
From the FDA notice · Read the official notice ↗ · All Lupin recalls
What to do
The agency's notice has the remedy and who to contact.
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Compare your label or packaging with the recalled product.
- 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
- Sold in
- FL, MA, MI & OH
- Made for
- Adults (0 months and older)
Details
- Units affected
- 32736 vials
- Illnesses reported
- None reported
- Manufactured in
- 5801 Pelican Bay Blvd, Suite 500, Naples, FL, United States
- Classification
- Class II
- Recall number
- D-0220-2026
In the FDA's words
- Description
- 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 Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity. Lot #: WB00006, Exp 12/31/2026 Distribution: FL, MA, MI & OH Affected quantity: 32736 vials
- Hazard
- Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
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