Tizanidine Tablet
FDA Recall NDC 67877-613
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Tizanidine (NDC 67877-613). A significant event, classified as Class II, was initiated on Nov 24, 2020 by Ascend Laboratories, Llc. The reported reason for this action was: "Failed Dissolution Specifications; Out of Specification (low) results were obtained."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
November 2020 Class II Recall: Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Recall Number
Class II Terminated
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Nov 24, 2020
Dec 09, 2020
1200 bottles
Recall Profile & Regulatory Data
Event ID
86859
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ascend Laboratories LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
MI
Termination Date
Apr 11, 2023
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.
Batch or Lot Expiration Information
Lot# 19143017, Exp. 05/31/2021
Affected Packages Involved in this Recall
67877-613-15Product
67877-613-05Product
67877-614-15Product
67877-614-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
