June 2023 FDA Recall Tizanidine by Dr Reddy's Laboratories Limited
D-0923-2023 - Failed dissolution specification
This Class II drug recall was initiated by Dr Reddy's Laboratories Limited on June 21, 2023 for the product Tizanidine. The FDA reported the reason for recall as failed dissolution specification. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0923-2023
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
06-21-2023
07-26-2023
17,548 1000-countbottles
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Dr Reddy's Laboratories Limited
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.
N/A
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10
Batch or Lot Expiration Information
Lot# Lot: T2100585, T2100586, T2100587, Exp 12/2023
