Ferring Recalls Endometrin Vaginal Inserts Due to Discoloration
Ferring Pharmaceuticals is recalling 72,046 cartons of Endometrin vaginal inserts nationwide due to discoloration caused by heat exposure.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a cosmetic defect (discoloration) without reported injuries.
Plain-English summary
Ferring Pharmaceuticals Inc. is recalling 72,046 cartons of Endometrin (progesterone) Vaginal Insert 100 mg USP. The product is a prescription-only medication distributed nationwide. The recall is being conducted because the product experienced discoloration due to prolonged heat exposure.
The affected lots include 0804.182B-1, 0804.183B-1, 0804.185A-1, 0804.186B-1, 0804.187B-1, 0804.210A-1, 0804.212A-1, 0804.213A-1, 0804.214A-1, 0804.216B-1, 0804.223B-1, and 0804.225B-1. These lots have expiry dates ranging from July 2014 to March 2015. The product is manufactured for Ferring Pharmaceuticals Inc. in Parsippany, NJ.
Consumers and healthcare providers should check their inventory for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures. The FDA has classified this recall as Class III, indicating that the violation is not likely to cause adverse health consequences.
The recalled product
- Product
- ENDOMETRIN (PROGESTERONE)
- Brand
- ENDOMETRIN
- Manufacturer
- Ferring Pharmaceuticals Inc
- Category
- Drug — Prescription Drug
- Affected units
- 72,046
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 (11)
- Lot Number:Expiry Date - 0804.182B-1:07/14
- 0804.183B-1:07/14
- 0804.185A-1:08/14
- 0804.186B-1:08/14
- 0804.187B-1:08/14
- 0804.210A-1:12/14
- 0804.212A-1:12/14
- 0804.213A-1:12/14
- 0804.214A-1:12/14
- 0804.216B-1:12/14
- 0804.223B-1:02/15 0804.225B-1:03/15
Distribution
Distributed nationwide across the United States.
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