D-0923-2023 Class II Ongoing
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