Gilead Sciences, Inc.

FDA Regulatory Profile

Summary

Total Recalls
7 (3 Class I)
510(k) Clearances
0
Inspections
27
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0005-2025Class IVeklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: GileadSeptember 19, 2024
D-0299-2022Class IVeklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: GileadDecember 3, 2021
D-0045-2015Class IIEmtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Manufactured for Gilead ScOctober 1, 2014
D-0013-2015Class IIITruvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, RSeptember 30, 2014
D-1090-2014Class IIIAtripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 TFebruary 19, 2014
D-821-2013Class IIAmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use VJune 20, 2013
D-324-2013Class IVistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: GJanuary 31, 2013