Home / Recalls / Gilead Sciences, Inc. / D-0013-2015

D-0013-2015 Class III Terminated

Recalled by Gilead Sciences, Inc. — Foster City, CA

Recall Details

Product Type
Drugs
Report Date
October 15, 2014
Initiation Date
September 30, 2014
Termination Date
May 11, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,317 bottles

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

Reason for Recall

Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.

Distribution Pattern

Nationwide

Code Information

TRUVADA (NDA 21-752; NDC 61958-0701-1) Lot# 002808, Expiration Date: 31 December 2017

Other recalls by Gilead Sciences, Inc.

  • D-0005-2025 Class I — Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manu (September 19, 2024)
  • D-0299-2022 Class I — Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manu (December 3, 2021)
  • D-0045-2015 Class II — Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Manufa (October 1, 2014)
  • D-1090-2014 Class III — Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 3 (February 19, 2014)
  • D-821-2013 Class II — AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusio (June 20, 2013)
  • D-324-2013 Class I — Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, (January 31, 2013)