Drug product
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
Product summary
- Event
- Event 66604
- Status
- Terminated
- Classification
- Class III
- Quantity
- 72,046 cartons
- Official record key
drug-enforcement:D-1426-2014
Official wording
Reason: Discoloration; due to prolonged heat exposure.
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
Distribution pattern: Nationwide.
Derived failure modes
-
Unknown
Discoloration; due to prolonged heat exposure.