D-0013-2015 Class III Terminated
FDA drug recall D-0013-2015 was initiated by Gilead Sciences, Inc. on September 30, 2014 and is designated Class III. Reason for recall: Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates. The recall status is terminated (terminated May 11, 2015). Affected quantity: 10,317 bottles.
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