The Harvard Drug Group: Drug Recall

Recall #D-0289-2022 · 08/03/2021

Class II: Risk

Recall Details

Recall Number: D-0289-2022
Classification: Class II
Product Type: Drug
Recalling Firm: The Harvard Drug Group
Status: Terminated
Date Initiated: 08/03/2021
Location: Livonia, MI, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,239 bottles

Reason for Recall

Failed Impurities/Degradation Specifications

Product Description

Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40

Distribution Pattern

Nationwide USA

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.