Drug & medication recalls Moderate risk

Modesa instant HAND SANITIZER with moisturizers & vitamin E 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 Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) bottle, Distributed…
Recall number
D-0028-2021
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

Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) bottle, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico. UPC 0 32251 49935 7

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