D-0923-2023 Class II Ongoing

Recalled by Dr Reddy's Laboratories Limited — Ranasthalam Mandal, Srikakulam, N/A

Recall Details

Product Type
Drugs
Report Date
July 26, 2023
Initiation Date
June 21, 2023
Termination Date
N/A
Voluntary/Mandated
N/A
Product Quantity
17,548 1000-countbottles

Product Description

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

Reason for Recall

Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.

Distribution Pattern

Nationwide in the USA

Code Information

Lot: T2100585, T2100586, T2100587, Exp 12/2023