Drug & medication recalls Moderate risk

Assured Instant Hand Sanitizer Aloe & Moisturizers / bottle recalled over manufacturing violations

Recall date
July 30, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Albek De Mexico S.A. De C.V. recalls Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Gre…
Recall number
D-0080-2021
FDA classification
Class II
Brand / firm
Albek De Mexico S.A. De C.V.
Sold / distributed
USA Nationwide

Why it was recalled

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer 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.

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 (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610

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