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Class II: temporary or reversible health riskTerminated

Ferring Pharmaceuticals Endometrin Recall

Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inse…

Ferring Pharmaceuticals Inc · Parsippany, NJ

Risk level
Class II
Reported by FDA
Jul 5, 2023
Recall ID
D-0879-2023
Check your lot numberHow we source this data

Summary

Ferring Pharmaceuticals recalled Endometrin starting Jun 12, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0879-2023 on Jul 5, 2023. Reason: cGMP deviations: potential for Microbial Contamination of Non-Sterile Products. Status: Terminated.

Why it was recalled

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

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 numbers, UPCs & expiration codes

AA200A, AA201A, Exp. 12/2025

Where it was sold

USA Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0879-2023
Classification
Class II
Status
Terminated
Recall initiated
Jun 12, 2023
FDA report date
Jul 5, 2023
Quantity
N/A
Recall type
N/A
Recalling firm
Ferring Pharmaceuticals Inc

Original FDA data

Every field from FDA enforcement report D-0879-2023, exactly as published.

Show all FDA fields
City
Parsippany
State
NJ
Status
Terminated
Country
United States
Event ID
92494
Address
100 Interpace Pkwy
Code information
AA200A, AA201A, Exp. 12/2025
Postal code
07054-1149
Report date
Jul 5, 2023
Product type
Drugs
Recall number
D-0879-2023
Classification
Class II
Recalling firm
Ferring Pharmaceuticals Inc
Termination date
Aug 5, 2024
Reason for recall
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
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
Distribution pattern
USA Nationwide
Recall initiation date
Jun 12, 2023
Center classification date
Jun 26, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0879-2023, published Jul 5, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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