Gilead Recalls Truvada Tablets Due to Silicone Rubber Particulates
Gilead Sciences is recalling Truvada tablets because they contain small red silicone rubber particulates. The recall affects 10,317 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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for minor or cosmetic defects.
Plain-English summary
Gilead Sciences, Inc. is recalling 10,317 bottles of Truvada (emtricitabine and tenofovir disoproxil fumarate) tablets. The product is a prescription medication manufactured in 30-count bottles. The recall is due to the presence of small red silicone rubber particulates in the tablets.
The affected product is identified by NDC 61958-0701-1, Lot # 002808, and an expiration date of 31 December 2017. The recall is classified as Class III by the FDA, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected bottles were distributed nationwide. Patients and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE)
- Brand
- TRUVADA
- Manufacturer
- Gilead Sciences, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 10,317
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)
- TRUVADA (NDA 21-752
- NDC 61958-0701-1) Lot# 002808
- Expiration Date: 31 December 2017
Distribution
Distributed nationwide across the United States.
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