FDAClass IIIOctober 15, 2014

Truvada recall: Particulate Matter

Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Sciences, Inc.…

Why was Truvada recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Sciences, Inc.…
Recalling firm
Gilead Sciences, Inc.
Quantity
10,317 bottles
Distribution
Nationwide
Recall date
October 15, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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