Drug product
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.
D-0894-2023
Product summary
- Event
- Event 92625
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 541 Bottles
- Official record key
drug-enforcement:D-0894-2023
Official wording
Reason: Failed Stability Specifications
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
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications