D-0806-2021 Class II Terminated
FDA drug recall D-0806-2021 was initiated by The Harvard Drug Group on July 29, 2021 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated February 19, 2023). Affected quantity: 1,632 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- September 29, 2021
- Initiation Date
- July 29, 2021
- Termination Date
- February 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,632 cartons
Product Description
Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC 0904-6822-04
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
CO, FL, MO, OH
Code Information
Lot, expiry: N00187, 05/2022; N00245, 06/2022; N00273, 07/2022; N00355, 11/2022