FDA Drugs recall ·
Progesterone Injection USP, 500mg per 10 mL (50mg/mL)… recall
- Recall number
- D-0186-2025
- Date
- (initiated December 27, 2024)
- Company / brand
- Eugia US LLC
279 Princeton Hightstown Rd, East Windsor, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 17,300 10-mL vials
- Hazard tags
- Foreign material
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Batch # 1PR24010, Expiry: 02/28/2027
Distribution
Distributed Nationwide in the USA.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0186-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.