Recalls / Class II
Class IID-0879-2023
Product
Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ NDC# 55566-6500-03
- Affected lot / code info
- AA200A, AA201A, Exp. 12/2025
Why it was recalled
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Recalling firm
- Firm
- Ferring Pharmaceuticals Inc
- Notification channel
- N/A
- Type
- N/A
- Address
- 100 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1149
Distribution
- Quantity
- N/A
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2023-06-12
- FDA classified
- 2023-06-26
- Posted by FDA
- 2023-07-05
- Terminated
- 2024-08-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0879-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.