D-0879-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 5, 2023
- Initiation Date
- June 12, 2023
- Termination Date
- August 5, 2024
- Voluntary/Mandated
- N/A
- Product Quantity
- N/A
Product Description
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
Reason for Recall
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Distribution Pattern
USA Nationwide
Code Information
AA200A, AA201A, Exp. 12/2025