Drug recall D-0862-2020
Product
Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count 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: Low out of specification dissolution result observed during stability testing.
Lots and codes
Lot #: 1342500A, Exp 10/2020
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Quantity
- 3,695 bottles
- Distribution
- Nationwide in the USA.
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 20, 2020
- Terminated
- October 6, 2020
Related products
- Mesalamine – drug information
- NDC 0591-2245 Mesalamine · Mesalamine 1.2 g/1 · Actavis Pharma, Inc.