FDA recall D-1090-2014

Product

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

Reason for recall

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

Distribution

Nationwide including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2014-02-19

Report date

2014-03-05

Termination date

2015-05-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Foster City, CA, United States

Primary source

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