Recalls / Class II
Class IID-0186-2025
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 name
- Progesterone
- Generic name
- Progesterone
- Active ingredient
- Progesterone
- Route
- Intramuscular
- NDC
- 55150-306
- FDA application
- ANDA210965
- Affected lot / code info
- Batch # 1PR24010, Expiry: 02/28/2027
Why it was recalled
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Recalling firm
- Firm
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 17,300 10-mL vials
- Distribution pattern
- Distributed Nationwide in the USA.
Timeline
- Recall initiated
- 2024-12-27
- FDA classified
- 2025-01-07
- Posted by FDA
- 2025-01-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0186-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.