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.

FDA recall notice · announced August 7, 2024 · Eugia Us

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

Presence of Particulate Matter: Complaint received of a glass particle in the vial.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: CPR230029A
Quantity: 17136 vials
Status: Ongoing
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.