The Harvard Drug Group: Drug Recall

Recall #D-0649-2022 · 02/28/2022

Class II: Risk

Recall Details

Recall Number: D-0649-2022
Classification: Class II
Product Type: Drug
Recalling Firm: The Harvard Drug Group
Status: Terminated
Date Initiated: 02/28/2022
Location: Livonia, MI, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 174 cartons

Reason for Recall

Failed Dissolution Specifications

Product Description

PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India. Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC: 0904-6937-61

Distribution Pattern

Nationwide within the United States

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 02/24/2022

Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Class II: Risk 08/06/2021

Failed Dissolution Specifications

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.