Reported Sep 3, 2014 · Terminated

VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX Only Manufactured…

Alkermes, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Alkermes, Inc. · 852 Winter St · Waltham, MA · 02451-1420

Is this the product you have?

  • 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.
Lot codes and dates
  • Batch Number
    • 412-3732AA
    • expiration date 07/2016 (NDC# 65757-302-02
  • Kit Pacaging Lot Number
    • 2013-021
    • expiration date 07/2016 (NDC# 65757-300-01
Amount recalled
4,364 vials

Where it was sold

  • Nationwide

Why it was recalled

Customer complaints for failure to deliver the dose.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 22, 2014 · Data as of Sep 19, 5:04 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.