Drug product
Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15.
D-0173-2021
Product summary
- Event
- Event 86859
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1200 bottles
- Official record key
drug-enforcement:D-0173-2021
Official wording
Reason: Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Code information: Lot #19143017, Exp. 05/31/2021
Distribution pattern: MI
Derived failure modes
-
Potency or specification failure
Out of Specification