FDA recall D-0432-2023

The Harvard Drug Group · Class II · drug

Product

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

Reason for recall

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

Distribution

Distributed Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2023-02-23
Report date: 2023-03-08
Termination date: 2024-04-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: La Vergne, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0432-2023