Recalls / Class II
Class IID-0624-2024
Product
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.
- Brand name
- Progesterone
- Generic name
- Progesterone
- Active ingredient
- Progesterone
- Route
- Intramuscular
- NDC
- 55150-306
- FDA application
- ANDA210965
- Affected lot / code info
- Lot #: CPR230029A
Why it was recalled
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Recalling firm
- Firm
- Eugia US LLC
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 17136 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-07-26
- FDA classified
- 2024-08-01
- Posted by FDA
- 2024-08-07
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0624-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.