FDA recall D-0100-2018

EAI-JR286 INC · Class II · drug

Product

Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50+, Net. Wt. 2.8 oz (80 g) tube in a carton, Distributed by Vertra/EAI-JR286, 20100 S Vermont Ave, Torrance, CA 90502, Made In Australia, UPC 8 94140 00103 0.

Reason for recall

CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.

Distribution

Nationwide in the USA and Puerto Rico.

Key facts

Status
Terminated
Initiation date
2017-11-28
Report date
2017-12-06
Termination date
2019-08-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Torrance, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0100-2018