Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, ...
FDA Recall #D-0892-2023 — Class II — June 23, 2023
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.
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.
Recalling Firm
Amerisource Health Services LLC — Columbus, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4,971 cartons
Distribution
Nationwide in the USA
Code Information
Lot 1004835, Exp 7/31/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated