Recalls / Class III

Class IIID-578-2013

Product

Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01

Affected lot / 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.

Why it was recalled

CGMP Deviation; cotton coil is missing in some packaged bottles

Recalling firm

Firm

Teva Pharmaceuticals USA, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

650 Cathill Rd, N/A, Sellersville, Pennsylvania 18960-1512

Distribution

Quantity

68,322 bottles

Distribution pattern

Nationwide

Timeline

Recall initiated

2013-03-19

FDA classified

2013-06-06

Posted by FDA

2013-06-12

Terminated

2013-12-24

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-578-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.