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
- Brand
- PROGESTERONE
- 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.
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