Drug Enforcement D-0879-2023

cGMP deviations: potential for Microbial Contamination of Non-Sterile Products

Status

Terminated

Classification

Class II

Report Date

July 5, 2023

Termination Date

August 5, 2024

Product Information

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
Product quantity
N/A
Reason for recall
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Recall initiation reason
—
Initial firm notification
N/A
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
Ferring Pharmaceuticals Inc
Address
100 Interpace Pkwy, N/A

United States
Voluntary / Mandated
N/A
Status date
—

Codes & Dates

Recall number
D-0879-2023
Event ID
92494
Recall initiation date
June 12, 2023
Center classification date
June 26, 2023
Code info
AA200A, AA201A, Exp. 12/2025
More code info
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