D-0879-2023 Class II Terminated

Recalled by Ferring Pharmaceuticals Inc — Parsippany, NJ

FDA drug recall D-0879-2023 was initiated by Ferring Pharmaceuticals Inc on June 12, 2023 and is designated Class II. Reason for recall: cGMP deviations: potential for Microbial Contamination of Non-Sterile Products The recall status is terminated (terminated August 5, 2024). Affected quantity: N/A.

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