Gilead Recalls Atripla Tablets Due to Foreign Silicone Particulates
Gilead Sciences is recalling specific lots of Atripla tablets because they contain red silicone rubber particulates. The recall covers 39,223 bottles distributed nationwide.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard involves foreign particulates, but no specific injury or illness is reported in the source text.
Plain-English summary
Gilead Sciences, Inc. is recalling 39,223 bottles of Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) tablets. The recall is due to the presence of red silicone rubber particulates in the drug product. The affected product is packaged in 30-tablet bottles and is prescription-only.
The affected lots are 002390 and 002400, with an expiration date of 02/17. The product was manufactured in Ireland for Bristol-Myers Squibb & Gilead Sciences, LLC. The recall covers distribution nationwide, including Puerto Rico.
Patients and healthcare providers should check their Atripla bottles for the specific lot numbers and expiration date listed above. If the product matches the recalled lots, it should be returned to the pharmacy or contact Gilead Sciences for further instructions.
The recalled product
- 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-Mye
- Manufacturer
- Gilead Sciences, Inc.
- Category
- Drug — Antiretroviral
- Hazard
- Affected units
- 39,223
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #'s: 002390
- 002400
- Exp 02/17.
Distribution
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