June 2023 FDA Recall Drug by Ferring Pharmaceuticals Inc
D-0879-2023 - cGMP deviations

This Class II drug recall was initiated by Ferring Pharmaceuticals Inc on June 12, 2023 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0879-2023

Reason for Recall
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Initiated
06-12-2023
Reported
07-05-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92494
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ferring Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
N/A
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-05-2024
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# AA200A, AA201A, Exp. 12/2025