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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Event Detail

Event ID 65092
Product Type Drugs
Status Ongoing
Recalling Firm Alkermes, Inc.
City Waltham
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-06
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01, Rx Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451, Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13 Class II Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing. 3,325 vials D-819-2013