D-0894-2023 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 12, 2023
- Initiation Date
- June 26, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 541 Bottles
Product Description
Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68788-7781-9), e) 120-count bottles (NDC: 68788-7781-8), Rx only, Mfg: Dr. Reddy's Laboratories Limited.
Reason for Recall
Failed Stability Specifications
Distribution Pattern
Nationwide within the United States
Code Information
Lot#: a) H1621S, Exp: 12/31/2023; b) H2321C, Exp: 12/31/2023; c) H0421B, Exp: 12/31/2023; d) H1721E, H1921T, H3121M, Exp: 12/31/2023, e) H2021G, Exp: 12/31/2023