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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Event Detail

Event ID 63511
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 2012-10-06
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide Japan

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
All Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com All lot codes Class II GMP Deviations D-053-2013
All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com All lot codes Class II Lack of Assurance of Sterility D-052-2013
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