February 2014 FDA Recall Drug by Gilead Sciences, Inc.
D-1090-2014 - Presence of Foreign Substance

This Class III drug recall was voluntarily initiated by Gilead Sciences, Inc. on February 19, 2014 for the product Drug. 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-1090-2014

Reason for Recall
Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
Initiated
02-19-2014
Reported
03-05-2014
Quantity
39,223 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67557
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-11-2015
Product Description About Product Description
Full technical description of the product.
Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 Tablet Bottles, Rx only. Manufactured for: Bristol-Myers Squibb & Gilead Sciences, LLC, Foster City, CA 94404. Made in Ireland. NDC 15584-0101-1. Manufactured for: Bristol-Myers-Squibb & Gilead Sciences, LLC, Foster City, CA 94404 Made in Ireland

Batch or Lot Expiration Information

Lot# 's: 002390, 002400, Exp 02/17.