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