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Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured i...

FDA Recall #D-0432-2023 — Class II — February 23, 2023

Recall #D-0432-2023 Date: February 23, 2023 Classification: Class II Status: Terminated

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.

Recalling Firm

The Harvard Drug Group — La Vergne, TN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

17,586 cartons

Distribution

Distributed Nationwide in the USA

Code Information

Lot: M04145 Exp. 01/2024

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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