The Harvard Drug Group: Drug Recall

Recall #D-0432-2023 · 02/23/2023

Class II: Risk

Recall Details

Recall Number: D-0432-2023
Classification: Class II
Product Type: Drug
Recalling Firm: The Harvard Drug Group
Status: Terminated
Date Initiated: 02/23/2023
Location: La Vergne, TN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 17,586 cartons

Reason for Recall

Packaging defect: observed packaging defect, blister packaging inadequately sealed.

Product Description

Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Packaged and Distributed by: Major Pharmaceuticals Indianapolis, IN 46268 USA. NDC 0904-7257-61, UPC 3 09047 25761 4

Distribution Pattern

Distributed Nationwide in the 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 02/28/2022

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

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