Drug recall D-0173-2021

Class II Terminated reported Dec 9, 2020

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.

Reason for recall

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

Lots and codes

Lot #19143017, Exp. 05/31/2021

Recall details

Recalling firm
Ascend Laboratories LLC, Parsippany, NJ
Quantity
1200 bottles
Distribution
MI
Type
Voluntary: Firm initiated
Recall initiated
November 24, 2020
Terminated
April 11, 2023

Related products