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U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

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Product Detail

Product Description VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03.
Recall Number D-1083-2014
Classification Class III
Code Info Lot #: 67603, Expiry: 2/2014
Product Distributed Qty 54,648 bottles
Reason For Recall Failed Stability Testing: This product is below specification for preservative content.

Event Detail

Event Id 67262
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 2013-12-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide including Puerto Rico