ASSURED Instant Hand Sanitizer Aloe & Moisturizers recalled over manufacturing violations

Recall date

July 11, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

4e Brands North America, Llc recalls ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6…

Recall number

D-0027-2021

FDA classification

Class II

Brand / firm

4e Brands North America, Llc

Sold / distributed

Distributed Nationwide in the USA

Why it was recalled

CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49070 4 b) 10 fL oz / 295 ml bottle, UPC 6 39277 49070 4, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico