Drug 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
D-1090-2014
Product summary
- Event
- Event 67557
- Status
- Terminated
- Classification
- Class III
- Quantity
- 39,223 bottles
- Official record key
drug-enforcement:D-1090-2014
Official wording
Reason: Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
Code information: Lot #'s: 002390, 002400, Exp 02/17.
Distribution pattern: Nationwide including Puerto Rico.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance