Recall
FDAHealthJuly 26, 2024

Eugia US LLC — 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.

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
July 26, 2024

Nationwide in the USA

What's affected?

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.
Lot code
CPR230029A

Additional details

Lot #: CPR230029A

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 17136 vials.

View original FDA notice →

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