Drug recall D-1090-2014

Class III Terminated reported Mar 5, 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.

Lots and codes

Lot #'s: 002390, 002400, Exp 02/17.

Recall details

Recalling firm
Gilead Sciences, Inc., Foster City, CA
Quantity
39,223 bottles
Distribution
Nationwide including Puerto Rico.
Type
Voluntary: Firm initiated
Recall initiated
February 19, 2014
Terminated
May 11, 2015