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

FDA recall notice · announced October 15, 2014 · Gilead Sciences

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide
Lot/code information: TRUVADA (NDA 21-752; NDC 61958-0701-1) Lot# 002808, Expiration Date: 31 December 2017
Quantity: 10,317 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0013-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.