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
Reported: March 5, 2014 Initiated: February 19, 2014 #D-1090-2014
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.
Details
- Recalling Firm
- Gilead Sciences, Inc.
- Units Affected
- 39,223 bottles
- Distribution
- Nationwide including Puerto Rico.
- Location
- Foster City, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Gilead Sciences, Inc.. Units affected: 39,223 bottles.
Why was this product recalled? ▼
Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 5, 2014. Severity: Low. Recall number: D-1090-2014.
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