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U.S. Department of Health and Human Services

Enforcement Report - Week of January 9, 2013

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Product Detail

Product Description Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA
Recall Number D-119-2013
Classification Class II
Code Info All lot codes
Product Distributed Qty 7055 vials
Reason For Recall Lack of Assurance of Sterility

Event Detail

Event Id 63305
Product Type Drugs
Status Ongoing
Recalling Firm New England Compounding Center
City Framingham
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-26
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide