March 2013 FDA Recall Drug by Teva Pharmaceuticals Usa, Inc.
D-578-2013 - CGMP Deviation; cotton coil is missing in some packaged bottles

This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc. on March 19, 2013 for the product Drug. The FDA reported the reason for recall as cgmp deviation; cotton coil is missing in some packaged bottles. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-578-2013

Reason for Recall
CGMP Deviation; cotton coil is missing in some packaged bottles
Initiated
03-19-2013
Reported
06-12-2013
Quantity
68,322 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64680
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-24-2013
Product Description About Product Description
Full technical description of the product.
Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01

Batch or Lot Expiration Information

Lot# 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.