Drug product
Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10
D-0186-2025
Product summary
- Firm
- Eugia US LLC
- Event
- Event 96073
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 17,300 10-mL vials
- Official record key
drug-enforcement:D-0186-2025
Official wording
Reason: Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Code information: Batch # 1PR24010, Expiry: 02/28/2027
Distribution pattern: Distributed Nationwide in the USA.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter