March 2013 FDA Recall Tizanidine by Dr. Reddy's Laboratories
D-238-2013 - Labeling Illegible
This Class III drug recall was voluntarily initiated by Dr. Reddy's Laboratories on March 19, 2013 for the product Tizanidine. The FDA reported the reason for recall as labeling illegible. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-238-2013
Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
03-19-2013
04-10-2013
117,546 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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
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 and Puerto Rico.
02-06-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepally - 500 090 India; NDC 55111-180-15.
Batch or Lot Expiration Information
Lot# : C208625, C208984, C209113, C209369, Exp 09/15; and C209680, Exp 10/15.
