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.
Reported: August 7, 2024 Initiated: July 26, 2024 #D-0624-2024
Product Description
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.
Reason for Recall
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Details
- Recalling Firm
- Eugia US LLC
- Units Affected
- 17136 vials
- Distribution
- Nationwide in the USA
- Location
- East Windsor, NJ
Frequently Asked Questions
What product 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.. Recalled by Eugia US LLC. Units affected: 17136 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 7, 2024. Severity: Moderate. Recall number: D-0624-2024.
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