FDA recall D-1670-2012

Island Kinetics dba Covalence · Class II · drug

Product

CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g), Distributed by CosMedix, LLC, Atlanta, GA --- Also labeled as RESULTS RX, Serious Protection Rx, SPF 28 Sunscreen, Net Wt. 4oz/120g.

Reason for recall

Microbial Contamination of Non Sterile Product; mold

Distribution

Atlanta, Georgia

Key facts

Status: Terminated
Initiation date: 2012-07-13
Report date: 2012-09-05
Termination date: 2013-09-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Chandler, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1670-2012