Home / Recalls / Gilead Sciences, Inc. / D-1090-2014

D-1090-2014 Class III Terminated

Recalled by Gilead Sciences, Inc. — Foster City, CA

Recall Details

Product Type
Drugs
Report Date
March 5, 2014
Initiation Date
February 19, 2014
Termination Date
May 11, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
39,223 bottles

Product Description

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

Reason for Recall

Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.

Distribution Pattern

Nationwide including Puerto Rico.

Code Information

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

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  • D-0045-2015 Class II — Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Manufa (October 1, 2014)
  • D-0013-2015 Class III — Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, (September 30, 2014)
  • D-821-2013 Class II — AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusio (June 20, 2013)
  • D-324-2013 Class I — Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, (January 31, 2013)