Recalls / Class III
Class IIID-1090-2014
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
- Affected lot / code info
- Lot #'s: 002390, 002400, Exp 02/17.
Why it was recalled
Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
Recalling firm
- Firm
- Gilead Sciences, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 333 Lakeside Dr, Foster City, California 94404-1147
Distribution
- Quantity
- 39,223 bottles
- Distribution pattern
- Nationwide including Puerto Rico.
Timeline
- Recall initiated
- 2014-02-19
- FDA classified
- 2014-02-27
- Posted by FDA
- 2014-03-05
- Terminated
- 2015-05-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1090-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.