Recalls / Class II
Class IID-0185-2025
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
- Brand name
- Medroxyprogesterone Acetate
- Generic name
- Medroxyprogesterone Acetate
- Active ingredient
- Medroxyprogesterone Acetate
- Route
- Intramuscular
- NDCs
- 55150-329, 55150-330
- FDA application
- ANDA212824
- Affected lot / code info
- Lot No.: 1MP24069, Exp.: 08/2026
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 19872 vials
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2024-12-18
- FDA classified
- 2025-01-06
- Posted by FDA
- 2025-01-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0185-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.