Drug recall D-0806-2021

Class II Terminated reported Sep 29, 2021

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

Lots and codes

Lot, expiry: N00187, 05/2022; N00245, 06/2022; N00273, 07/2022; N00355, 11/2022

Recall details

Recalling firm
The Harvard Drug Group, Livonia, MI
Quantity
1,632 cartons
Distribution
CO, FL, MO, OH
Type
Voluntary: Firm initiated
Recall initiated
July 29, 2021
Terminated
February 19, 2023

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