Class II · Moderate risk Terminated
Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Manufactured for Gilead Sciences, Inc., Foster City, CA…
Reason Defective Container; leaking around the cap
Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
What was recalled
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
- Recalling firm
- Gilead Sciences, Inc.
- NDC code
- 61958-0701-1
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0013-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Emtricitabine recalls
See all
Class III · Low risk Terminated
Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 Tablet Bottles, Rx only…
Reason Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
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