RecallDepth
Class III Terminated

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

Company
Gilead Sciences, Inc.
Recall Initiated
February 19, 2014
Posted
March 5, 2014
Recall Number
D-1090-2014
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
39,223 bottles
Firm Location
Foster City, CA, United States

Reason for Recall

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

Distribution

Nationwide including Puerto Rico.

Lot / Code Info

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

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