FDA recall D-0013-2015

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-09-30

Report date

2014-10-15

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-0013-2015