Teva Pharmaceuticals USA recalls Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL,
Recalled March 11, 2020 · FDA recall D-0862-2020 · Teva Pharmaceuticals USA
Hazard
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing. · FDA Class II
Units
3,695 bottles
Sold at
Nationwide in the USA.
Description
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
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.
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →