The Harvard Drug Group: Drug Recall

Recall #D-0807-2021 · 08/06/2021

Class II: Risk

Recall Details

Recall Number: D-0807-2021
Classification: Class II
Product Type: Drug
Recalling Firm: The Harvard Drug Group
Status: Terminated
Date Initiated: 08/06/2021
Location: Livonia, MI, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4 Cartons of 100 count each

Reason for Recall

Failed Dissolution Specifications

Product Description

Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-392130, India; Manufactured for: Torrent Pharma, Inc., Basking Ridge, NJ 07920; Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC 0904-6172-61

Distribution Pattern

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.