Drug recall D-0013-2015

Class III Terminated reported Oct 15, 2014

Product

Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Sciences, Inc. Foster City, CA 94404, NDC 61958-0701-1

Reason for recall

Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.

Lots and codes

TRUVADA (NDA 21-752; NDC 61958-0701-1) Lot# 002808, Expiration Date: 31 December 2017

Recall details

Recalling firm
Gilead Sciences, Inc., Foster City, CA
Quantity
10,317 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
September 30, 2014
Terminated
May 11, 2015

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