FDA recall D-0806-2021

The Harvard Drug Group · Class II · drug

Product

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

CO, FL, MO, OH

Key facts

Status: Terminated
Initiation date: 2021-07-29
Report date: 2021-09-29
Termination date: 2023-02-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Livonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0806-2021