November 2020 FDA Recall Tizanidine by Ascend Laboratories Llc (D-0173-2021 - Failed Dissolution Specifications; Out of Specification (low) results were obtained.)

This Class II drug recall was voluntarily initiated by Ascend Laboratories Llc on November 24, 2020 for the product Tizanidine. The FDA reported the reason for recall as failed dissolution specifications; out of specification (low) results were obtained.. The product was distributed in MI and the recall is currently terminated.

Recall Number: D-0173-2021

Reason for Recall
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Initiated
11-24-2020
Reported
12-09-2020
Quantity
1200 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86859
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ascend Laboratories LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-11-2023
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 19143017, Exp. 05/31/2021

Affected Packages Involved in this Recall

67877-613-15 Tizanidine
67877-613-05 Tizanidine
67877-614-15 Tizanidine
67877-614-05 Tizanidine