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U.S. Department of Health and Human Services

Enforcement Report - Week of August 20, 2014

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Product Detail

Product Description Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured in Israel by Teva Pharmaceutical IND, LTD., Jeruselem, Israel, for Teva Pharmaceuticals USA, Sellersville, PA, NDC 0093-0293-10
Recall Number D-1538-2014
Classification Class II
Code Info lot 29C220, Exp. 11/15
Product Distributed Qty 3881bottles
Reason For Recall Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets.

Event Detail

Event Id 68522
Product Type Drugs
Status Ongoing
Recalling Firm Teva Pharmaceuticals USA
City North Wales
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-06-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide