Reported Mar 5, 2014 · Terminated

Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 Tablet Bottles, Rx…

Gilead Sciences, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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: Gilead Sciences, Inc. · 333 Lakeside Dr · Foster City, CA · 94404-1147

Is this the product you have?

  • Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 Tablet Bottles, Rx only
  • Manufactured forBristol-Myers Squibb & Gilead Sciences, LLC, Foster City, CA 94404. Made in Ireland. NDC 15584-0101-1
  • Manufactured forBristol-Myers-Squibb & Gilead Sciences, LLC, Foster City, CA 94404 Made in Ireland
Lot codes and dates
    • Lot #'s: 002390
    • 002400
    • Exp 02/17
Amount recalled
39,223 bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated May 11, 2015 · Data as of Sep 19, 7:55 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.