FDA recall D-1583-2020

Real Clean Distribuciones SA de CV · Class I · drug

Product

BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3, Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018.

Reason for recall

Chemical Contamination: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Distribution

Distributed Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2020-07-23
Report date
2020-09-23
Termination date
2022-05-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tlalnepantla De Baz, N/A, Mexico

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1583-2020