FDA-Drug2013-07-31Class II
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,
Alkermes, Inc.
Hazard
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Sold states
Nationwide
Affected count
3,325 vials
Manufactured in
852 Winter St, N/A, Waltham, MA, United States
Products
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,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-819-2013Don't want to check this manually?
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