Drug product
medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspension, USP, 150 mg per mL, Distributed by: Eugia US LLC, NJ, Manufactured by: Eugia Pharma Specialties Limited, India
D-0185-2025
Product summary
- Firm
- Eugia US LLC
- Event
- Event 96018
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 19872 vials
- Official record key
drug-enforcement:D-0185-2025
Official wording
Reason: CGMP Deviations
Code information: Lot No.: 1MP24069, Exp.: 08/2026
Distribution pattern: Nationwide in the US
Derived failure modes
-
Manufacturing or process control
CGMP Deviations