September 2014 FDA Recall Truvada by Gilead Sciences, Inc.
D-0013-2015 - Presence of Foreign Substance
This Class III drug recall was voluntarily initiated by Gilead Sciences, Inc. on September 30, 2014 for the product Truvada. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0013-2015
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
09-30-2014
10-15-2014
10,317 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Gilead Sciences, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
05-11-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# TRUVADA (NDA 21-752; NDC 61958-0701-1)
Lot# 002808, Expiration Date: 31 December 2017
