FDA recall D-0045-2015

Gilead Sciences, Inc. · Class II · drug

Product

Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Manufactured for Gilead Sciences, Inc., Foster City, CA NDC 61958-0602-1 Gilead Sciences, Inc. Foster City, CA 94404.

Reason for recall

Defective Container; leaking around the cap

Distribution

United States, Puerto Rico, Fiji.

Key facts

Status: Terminated
Initiation date: 2014-10-01
Report date: 2014-11-05
Termination date: 2015-05-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Foster City, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0045-2015