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.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Category
- Drug — Vaginal Insert
- Hazard
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.
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