FDA-Drug2023-03-08Class II

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

The Harvard Drug Group
Hazard

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

Sold states
Distributed Nationwide in the USA
Affected count
17,586 cartons
Manufactured in
341 Mason Rd, N/A, La Vergne, TN, United States
Products
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

Official notice

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

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