Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories ...
FDA Recall #D-0173-2021 — Class II — November 24, 2020
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.
Reason for Recall
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Recalling Firm
Ascend Laboratories LLC — Parsippany, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1200 bottles
Distribution
MI
Code Information
Lot #19143017, Exp. 05/31/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated