FDAFDA · Food and drugs·Recall number D-1090-2014
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
Published March 5, 2014 · Recall initiated: February 19, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Gilead Sciences, Inc.
- Distributor
- Nationwide including Puerto Rico.
- Lot
- Lot #'s: 002390, 002400, Exp 02/17.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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