ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3

FDA recall notice · announced July 16, 2014 · Ferring Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3

Reason for recall

Discoloration; due to prolonged heat exposure.

Notes

Distribution: Nationwide.
Lot/code information: 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
Quantity: 72,046 cartons
Status: Terminated
Products in this recall event:
- ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3 (D-1426-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.