AVKARE Inc. recalls Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc
Recalled November 18, 2020 · FDA recall D-0070-2021 · AVKARE
Hazard
Failed Dissolution Specifications · FDA Class II
Units
15,678 bottles
Sold at
Nationwide
Description
Failed Dissolution Specifications
Product
Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12
Manufacturer(s)
AVKARE Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →