Truvada Tablet, Film Coated
FDA Recall NDC 61958-0701
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Truvada (NDC 61958-0701). A significant event, classified as Class III, was initiated on Sep 30, 2014 by Gilead Sciences, Inc. The reported reason for this action was: "Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Sep 30, 2014
Oct 15, 2014
10,317 bottles
Recall Profile & Regulatory Data
Event ID
69414
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Gilead Sciences, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
May 11, 2015
Product Description
Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Sciences, Inc. Foster City, CA 94404, NDC 61958-0701-1
Batch or Lot Expiration Information
Lot# TRUVADA (NDA 21-752; NDC 61958-0701-1)
Lot# 002808, Expiration Date: 31 December 2017
Affected Packages Involved in this Recall
61958-0701-1Product
61958-0703-1Product
61958-0704-1Product
61958-0705-1Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
