Alkermes, Inc.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
14
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0119-2020Class IIVivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: September 26, 2019
D-1846-2019Class IIVivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: August 8, 2019
D-1556-2014Class IIVIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX March 4, 2014
D-819-2013Class IIVIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b)November 6, 2012