The Recall Desk
HighFDA (Drugs)·D-0879-2023·Announced 2023-07-05

Endometrin Vaginal Inserts Recalled Due to Potential Microbial Contamination

Ferring Pharmaceuticals is recalling certain lots of Endometrin (progesterone) Vaginal Inserts due to potential microbial contamination resulting from manufacturing deviations.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving potential microbial contamination of a vaginal pharmaceutical product. No illnesses or injuries have been reported, and the source describes the contamination as 'potential,' indicating a theoretical hazard. Per the rubric, high-risk contamination risks without reported illness are scored at most 3 (High).

Plain-English summary

Ferring Pharmaceuticals Inc. is recalling Endometrin (progesterone) Vaginal Insert 100mg (NDC# 55566-6500-03), packaged in cartons of 21 vaginal inserts with 21 disposable applicators. The affected product has lot codes AA200A and AA201A with expiration date 12/2025 and was distributed nationwide in the USA.

The recall was initiated due to deviations from current good manufacturing practices (cGMP) that created a potential for microbial contamination of the product.

Patients and healthcare providers who have received product from the affected lots should contact their healthcare provider regarding this recall.

The recalled product

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
Manufacturer
Ferring Pharmaceuticals Inc
Hazard
  • microbial-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • AA200A
  • AA201A
  • Exp. 12/2025

Distribution

Distributed nationwide across the United States.