Drug 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
D-0013-2015
Product summary
- Event
- Event 69414
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10,317 bottles
- Official record key
drug-enforcement:D-0013-2015
Official wording
Reason: Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Code information: TRUVADA (NDA 21-752; NDC 61958-0701-1) Lot# 002808, Expiration Date: 31 December 2017
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance