Drug product
Progesterone Injection, USP, 500 mg 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-0624-2024
Product summary
- Firm
- Eugia US LLC
- Event
- Event 95059
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 17136 vials
- Official record key
drug-enforcement:D-0624-2024
Official wording
Reason: Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Code information: Lot #: CPR230029A
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter