drugs Class II Updated 2013-07-31

Alkermes, Inc. recalls VIVITROL (naltrexone for extended-release injectable suspens

Recalled Product

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,

Hazard / Issue

Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13
View official government recall

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