Drug 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
D-0220-2026
Product summary
- Event
- Event 97990
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 32736 vials
- Official record key
drug-enforcement:D-0220-2026
Official wording
Reason: Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Code information: Lot #: WB00006, Exp 12/31/2026
Distribution pattern: FL, MA, MI & OH
Derived failure modes
-
Potency or specification failure
out of specification