Drug & medication recalls Moderate risk

Eugia US LLC recalls Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Mfd. in India for: Eugia US…

Recall date
July 26, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0624-2024
FDA classification
Class II
Brand / firm
Eugia US LLC
Sold / distributed
Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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