Teva Pharmaceuticals USA recalls Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories
Recalled November 18, 2020 · FDA recall D-0069-2021 · Teva Pharmaceuticals USA
Hazard
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing. · FDA Class II
Units
133,829 bottles
Sold at
Nationwide in the U.S. and PR
Description
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
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.
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →