FDA recall D-1242-2020

Filltech USA, LLC · Class II · drug

Product

Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC: 08705272732; c) 4 FL. OZ. (118 mL) tubes, UPC: 087052727345, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144

Reason for recall

Microbial contamination of non-sterile products: positive test for yeast and bacteria.

Distribution

USA Nationwide

Key facts

Status
Terminated
Initiation date
2020-03-19
Report date
2020-04-22
Termination date
2022-01-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rockwell, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1242-2020