Drug recall D-0069-2021
Product
Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, NDC 0591-2245-22.
Reason for recall
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Lots and codes
Lot #s: 1342498A, Exp. 12/2020; 1342499A, Exp. 01/2021; 1354638A, Exp. 03/2021; 1354639A, 1358274A, 1358448A, 1364618A, 1369884A, Exp. 05/2021; 1366195A, 1369885A, 1373570A, Exp. 06/2021; 1373571A, Exp. 07/2021; 1388571A, Exp. 01/2022; 1395725A, 1396585A, 1397550A, 1399389A, Exp. 04/2022; 1403885A, 1403886A, Exp. 06/2022.
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Quantity
- 133,829 bottles
- Distribution
- Nationwide in the U.S. and PR
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 28, 2020
- Terminated
- August 26, 2021
Related products
- Mesalamine – drug information
- NDC 0591-2245 Mesalamine · Mesalamine 1.2 g/1 · Actavis Pharma, Inc.