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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Product Detail

Product Description Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15
Recall Number D-1663-2012
Classification Class III
Code Info Lot S1P272A Expiry Date: December 2014
Product Distributed Qty 47,750 vials
Reason For Recall Short Fill: The product is being recalled due to a potential underfill of the affected vials.

Event Detail

Event Id 62636
Product Type Drugs
Status Ongoing
Recalling Firm Bracco Diagnostic Inc
City Princeton
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide