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U.S. Department of Health and Human Services

Enforcement Report - Week of March 5, 2014

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Product Detail

Product Description 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
Recall Number D-1090-2014
Classification Class III
Code Info Lot #'s: 002390, 002400, Exp 02/17.
Product Distributed Qty 39,223 bottles
Reason For Recall Presence of Particulate Matter: Red Silicone Rubber Particulates are Present in Drug.

Event Detail

Event Id 67557
Product Type Drugs
Status Ongoing
Recalling Firm Gilead Sciences, Inc.
City Foster City
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide including Puerto Rico.