Class III
Terminated
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
This recall has been terminated (originally issued March 5, 2014).
- Company
- Gilead Sciences, Inc.
- Recall Initiated
- February 19, 2014
- Posted
- March 5, 2014
- Recall Number
- D-1090-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 39,223 bottles
- Firm Location
- Foster City, CA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
Distribution
Nationwide including Puerto Rico.
Lot / Code Info
Lot #'s: 002390, 002400, Exp 02/17.
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