US Drug Recall Register
Class III · Low risk Terminated Initiated Feb 19, 2014 (13 years ago)

Atripla

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.

What 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

Recalling firm
Gilead Sciences, Inc.
NDC code
15584-0101-1
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1090-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Efavirenz recalls

See all
Class II · Moderate risk Terminated

Efavirenz

Reason Labeling: Label Mixup: EFAVIRENZ, Tablet, 600 mg may have potentially been mislabeled as the following drug: NIACIN ER, Tablet, 500 mg, NDC 00074307490, Pedigree: AD73637_1, EXP: 5/30/2014.

Aidapak Services, LLC D-801-2014
Class II · Moderate risk Terminated

Efavirenz

Reason Labeling: Label Mixup: EFAVIRENZ, Capsule, 200 mg may have potentially been mislabeled as the following drug: metFORMIN HCl, Tablet 500 mg, NDC 23155010201, Pedigree: AD46312_25, EXP: 5/16/2014.

Aidapak Services, LLC D-800-2014