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
Reported: January 15, 2025 Initiated: December 27, 2024 #D-0186-2025
Product Description
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
Reason for Recall
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Details
- Recalling Firm
- Eugia US LLC
- Units Affected
- 17,300 10-mL vials
- Distribution
- Distributed Nationwide in the USA.
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Eugia US LLC. Units affected: 17,300 10-mL vials.
Why was this product recalled? ▼
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 15, 2025. Severity: Moderate. Recall number: D-0186-2025.
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