Drug & medication recalls Moderate risk

Bio aaa Alcohol en Gel Antibacterial recalled over manufacturing violations

Recall date
September 3, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
AJR TRADING LLC recalls bio aaa Alcohol en Gel Antibacterial, Alcohol al 70% Cont. Neto 480 ml bottle, Hecho en Mexico por: AAA Cosmetica S.A.…
Recall number
D-1620-2020
FDA classification
Class II
Brand / firm
AJR TRADING LLC
Sold / distributed
Distributed in Florida

Why it was recalled

CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.

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

What was recalled

bio aaa Alcohol en Gel Antibacterial, Alcohol al 70% Cont. Neto 480 ml bottle, Hecho en Mexico por: AAA Cosmetica S.A. DE C.V. Recursos Hidraulicos No. 1 Secc. A, Col La Loma Zona Industrial, Tlalnepantla de Baz C.P. 54060 Edo. Mexico. UPC 7 502272 12108 5

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