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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Product Detail

Product Description Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53
Recall Number D-914-2013
Classification Class III
Code Info Lot #65846
Product Distributed Qty 3,096 bottles
Reason For Recall Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.

Event Detail

Event Id 66032
Product Type Drugs
Status Ongoing
Recalling Firm Bracco Diagnostics Inc
City Monroe Township
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide