Recall: D-0173-2021
Class II - Potentially Harmful
Class IIClassification
2020-11-24Initiated
TerminatedStatus
Ascend Laboratories LLCFirm
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
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Distribution
MI
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.