FDAHealthDecember 18, 2024
Eugia US LLC — 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: medroxyPR
⚠️ CGMP Deviations
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 18, 2024
Nationwide in the US
What's affected?
- 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
- UPC
- 0355150330010
- Lot code
- No
Additional details
Lot No.: 1MP24069, Exp.: 08/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 19872 vials.
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