Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal ap
Summary
The FDA issued a Class II for Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vagin by Ferring Pharmaceuticals Inc. Reason: cGMP deviations: potential for Microbial Contamination of Non-Sterile Products.
Details
Source
Drug Recall
External ID
D-0879-2023
Action Date
2023-07-05
Status
Terminated
Category
drug
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
Lot/Code Info: AA200A, AA201A, Exp. 12/2025
Quantity Affected: N/A
Reason for Recall
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Distribution
USA Nationwide
Type: N/A
Recall Initiated: 2023-06-12
Company
Parsippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 40 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ferring Pharmaceuticals Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ferring Pharmaceuticals Inc have FDA actions?
This is the only FDA action we have on record for Ferring Pharmaceuticals Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0879-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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