FDA recall D-0173-2021

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.

Distribution

MI

Key facts

Status

Terminated

Initiation date

2020-11-24

Report date

2020-12-09

Termination date

2023-04-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0173-2021