D-0173-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 9, 2020
- Initiation Date
- November 24, 2020
- Termination Date
- April 11, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1200 bottles
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.
Distribution Pattern
MI
Code Information
Lot #19143017, Exp. 05/31/2021