Drug product
Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-645-01 (carton), barcode (01) 003 68084 645 11 2.
D-0892-2023
Product summary
- Event
- Event 92607
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,971 cartons
- Official record key
drug-enforcement:D-0892-2023
Official wording
Reason: Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Code information: Lot 1004835, Exp 7/31/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out of specification