D-0892-2023 Class II Terminated
FDA drug recall D-0892-2023 was initiated by Amerisource Health Services LLC on June 23, 2023 and is designated Class II. 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. The recall status is terminated (terminated September 6, 2024). Affected quantity: 4,971 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- July 12, 2023
- Initiation Date
- June 23, 2023
- Termination Date
- September 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,971 cartons
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot 1004835, Exp 7/31/2023