Recalls / Class III
Class IIID-0013-2015
Product
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
- Brand name
- Truvada
- Generic name
- Emtricitabine And Tenofovir Disoproxil Fumarate
- Active ingredients
- Emtricitabine, Tenofovir Disoproxil Fumarate
- Route
- Oral
- NDCs
- 61958-0701, 61958-0703, 61958-0704, 61958-0705
- FDA application
- NDA021752
- Affected lot / code info
- TRUVADA (NDA 21-752; NDC 61958-0701-1) Lot# 002808, Expiration Date: 31 December 2017
Why it was recalled
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Recalling firm
- Firm
- Gilead Sciences, Inc.
- Manufacturer
- Gilead Sciences, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 333 Lakeside Dr, Foster City, California 94404-1147
Distribution
- Quantity
- 10,317 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-09-30
- FDA classified
- 2014-10-09
- Posted by FDA
- 2014-10-15
- Terminated
- 2015-05-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0013-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.