Alkermes, Inc. recalls VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit
Recalled July 31, 2013 · FDA recall D-819-2013 · Alkermes
Hazard
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing. · FDA Class II
Units
3,325 vials
Sold at
Nationwide
Description
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
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,
Manufacturer(s)
Alkermes, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →