PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 8, 2023 Initiated: February 23, 2023 #D-0432-2023

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

Reason for Recall

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

Details

Recalling Firm
The Harvard Drug Group
Units Affected
17,586 cartons
Distribution
Distributed Nationwide in the USA
Location
La Vergne, TN

Frequently Asked Questions

What product was recalled?
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. Recalled by The Harvard Drug Group. Units affected: 17,586 cartons.
Why was this product recalled?
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 8, 2023. Severity: Moderate. Recall number: D-0432-2023.