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.
Recall Number: D-0892-2023
Firm: Amerisource Health Services LLC
Classification: Class II
Status: Terminated
Report Date: 20230712
Initiation Date: 20230623
Termination Date: 20240906
Reason for Recall
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Product Description
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.