Recall
FDAHealthDecember 27, 2024

Eugia US LLC — 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

⚠️ Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
December 27, 2024

Distributed Nationwide in the USA.

What's affected?

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
Lot code
Batch # 1PR24010, Expiry: 02/28/2027

Additional details

Batch # 1PR24010, Expiry: 02/28/2027

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 17,300 10-mL vials.

View original FDA notice →

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