Why it was recalled
CGMP Deviations
Product description
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
Lot numbers, UPCs & expiration codes
Lot No.: 1MP24069, Exp.: 08/2026
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0185-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 18, 2024
- FDA report date
- Jan 15, 2025
- Quantity
- 19872 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eugia US LLC
Original FDA data
Every field from FDA enforcement report D-0185-2025, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96018
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot No.: 1MP24069, Exp.: 08/2026
- Postal code
- 08520-1401
- Report date
- Jan 15, 2025
- Product type
- Drugs
- Recall number
- D-0185-2025
- Classification
- Class II
- Recalling firm
- Eugia US LLC
- Product quantity
- 19872 vials
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Dec 18, 2024
- Initial firm notification
- Letter
- Center classification date
- Jan 6, 2025