Drug & medication recalls Moderate risk

HAND SANITIZER recalled over sterility concerns

Recall date
September 2, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Charles Paint Research Inc recalls HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (…
Recall number
D-0791-2021
FDA classification
Class II
Brand / firm
Charles Paint Research Inc
Sold / distributed
Distributed in Michigan

Why it was recalled

CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.

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

What was recalled

HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 gallon; Net Quantity (3785 mL), Manufactured by Soapdaddy LLC, 2401 E. 85th Street, Kansas City, MO 64131

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