FDAClass IIJuly 5, 2023

Endometrin recall: Sterility Concern

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

Why was Endometrin recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

AA200A, AA201A, Exp. 12/2025

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
Recalling firm
Ferring Pharmaceuticals Inc
Quantity
N/A
Distribution
USA Nationwide
Recall date
July 5, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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