D-1090-2014 Class III Terminated
FDA drug recall D-1090-2014 was initiated by Gilead Sciences, Inc. on February 19, 2014 and is designated Class III. Reason for recall: Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug. The recall status is terminated (terminated May 11, 2015). Affected quantity: 39,223 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 5, 2014
- Initiation Date
- February 19, 2014
- Termination Date
- May 11, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39,223 bottles
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.
Distribution Pattern
Nationwide including Puerto Rico.
Code Information
Lot #'s: 002390, 002400, Exp 02/17.