The Harvard Drug Group: Drug Recall

Recall #D-0806-2021 · 07/29/2021

Class II: Risk

Recall Details

Recall Number: D-0806-2021
Classification: Class II
Product Type: Drug
Recalling Firm: The Harvard Drug Group
Status: Terminated
Date Initiated: 07/29/2021
Location: Livonia, MI, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,632 cartons

Reason for Recall

Failed Dissolution Specifications

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

Distribution Pattern

CO, FL, MO, OH

Other Recalls by The Harvard Drug Group

Class II: Risk 06/16/2023

Packaging defect: blister packaging inadequately sealed.
Class III: Low Risk 04/24/2023

Product mixup: one foreign tablet found in product.
Class II: Risk 02/23/2023

Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Class II: Risk 02/28/2022

Failed Dissolution Specifications
Class II: Risk 02/24/2022

Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.

View all recalls by The Harvard Drug Group →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.