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.

Recall Number: D-0173-2021

Firm: Ascend Laboratories LLC

Classification: Class II

Status: Terminated

Report Date: 20201209

Initiation Date: 20201124

Termination Date: 20230411

Reason for Recall

Failed Dissolution Specifications; Out of Specification (low) results were obtained.

Product Description

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.

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Data source: openFDA · Updated regularly