Ascend Laboratories LLC recalls Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013,
Recalled December 9, 2020 · FDA recall D-0173-2021 · Ascend Laboratories
Hazard
Failed Dissolution Specifications; Out of Specification (low) results were obtained. · FDA Class II
Units
1200 bottles
Sold at
MI
Description
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Product
Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15.
Manufacturer(s)
Ascend Laboratories LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →