Product Detail

Product Description Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only,

Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01

Recall Number D-578-2013

Classification Class III

Code Info NDC 0093-5035-01, Lot numbers 14064211A, exp 3/2014; 14064311A, exp 3/2014; 14064411A, exp 3/2014; 14064511A, exp 3/2014; 14090312A, exp 4/2015; 14092512A, exp 4/2015; 14092712A, exp 4/2015; 14094612A, exp 4/2015; 14099412A, exp 4/2015; 14099612B, exp 4/2015; 14099712A, exp 5/2015; 14110111A, exp 5/2014; 14110211A, exp 5/2014; 14110311A, exp 5/2014; 14110411A, exp 5/2014 and 34090212A, exp 4/2015.
Product Distributed Qty 68,322 bottles

Reason For Recall CGMP Deviation; cotton coil is missing in some packaged bottles

Event Detail

Event Id 64680

Product Type Drugs

Status Ongoing

Recalling Firm
Teva Pharmaceuticals USA, Inc.
City Sellersville

State PA
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-03-19

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide