FDA-Drug2014-03-05Class III

Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 Tablet Bottles, Rx only. Manufactured for: Bristol-Myers Squibb & Gilead Sciences, LLC, Foster City, CA 94404. Made in Ireland. NDC 15584-0101-1. Manufactured for: Bristol-Myers-Squibb & Gilead Sciences, LLC, Foster City, CA 94404 Made in Ireland

Gilead Sciences, Inc.
Hazard

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

Sold states
Nationwide including Puerto Rico.
Affected count
39,223 bottles
Manufactured in
333 Lakeside Dr, Foster City, CA, United States
Products
Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 Tablet Bottles, Rx only. Manufactured for: Bristol-Myers Squibb & Gilead Sciences, LLC, Foster City, CA 94404. Made in Ireland. NDC 15584-0101-1. Manufactured for: Bristol-Myers-Squibb & Gilead Sciences, LLC, Foster City, CA 94404 Made in Ireland

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1090-2014

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