Drug 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
D-0879-2023
Product summary
- Event
- Event 92494
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0879-2023
Official wording
Reason: cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Code information: AA200A, AA201A, Exp. 12/2025
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations
-
Microbial contamination
Microbial Contamination