Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major...
FDA Recall #D-0806-2021 — Class II — July 29, 2021
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
Recalling Firm
The Harvard Drug Group — Livonia, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,632 cartons
Distribution
CO, FL, MO, OH
Code Information
Lot, expiry: N00187, 05/2022; N00245, 06/2022; N00273, 07/2022; N00355, 11/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated