FDA recall D-1582-2020

Real Clean Distribuciones SA de CV · Class II · drug

Product

LUX EOI Hand Sanitizing Gel, (Ethyl Alcohol 70%), (16.9 FL OZ) 500mL bottle, Distributed by: Procurement Services, LLC Nashville, TN 37215, Product of Mexico. NDC 74882-007-02

Reason for recall

CGMP Deviations: 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-1582-2020