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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Detail

Product Description 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,
Recall Number D-819-2013
Classification Class II
Code Info Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13
Product Distributed Qty 3,325 vials
Reason For Recall Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.

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 Letter
Distribution Pattern Nationwide