June 2023 FDA Recall Tizanidine by Amerisource Health Services Llc
D-0892-2023 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by Amerisource Health Services Llc on June 23, 2023 for the product Tizanidine. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0892-2023

Reason for Recall
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Initiated
06-23-2023
Reported
07-12-2023
Quantity
4,971 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92607
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.
Amerisource Health Services 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-06-2024
Product Description About Product Description
Full technical description of the product.
Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-645-01 (carton), barcode (01) 003 68084 645 11 2.

Batch or Lot Expiration Information

Lot# Lot 1004835, Exp 7/31/2023

Affected Packages Involved in this Recall

68084-645-11 Tizanidine
68084-645-01 Tizanidine
68084-645-65 Tizanidine
68084-775-95 Tizanidine
68084-775-25 Tizanidine