July 2021 FDA Recall Tizanidine by Dr. Reddy's Laboratories, Inc.
D-0750-2021 - Failed Tablet/Capsule Specification
This Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on July 19, 2021 for the product Tizanidine. The FDA reported the reason for recall as failed tablet/capsule specification. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0750-2021
Failed Tablet/Capsule Specification: Some tablets are shaved
07-19-2021
08-25-2021
37560 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
12-21-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDIA, NDC 55111-180-15.
Batch or Lot Expiration Information
Lot# : T2000471, exp date 09/2023
