FDA recall D-1556-2014

Alkermes, Inc. · Class II · drug

Product

VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451.

Reason for recall

Customer complaints for failure to deliver the dose.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2014-03-04
Report date: 2014-09-03
Termination date: 2014-12-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1556-2014