FDA recall D-819-2013

Alkermes, Inc. · Class II · drug

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,

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.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2012-11-06
Report date: 2013-07-31
Termination date: 2013-08-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-819-2013