ROCK TOWN - DISTILLERY - HAND SANITIZER recalled over manufacturing violations

Recall date

March 10, 2022

Source

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

Official notice title

Rock Town Distillery, Inc. recalls ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solution packaged in a) 375 mL (12.7 fl. oz.),…

Recall number

D-0715-2022

FDA classification

Class II

Brand / firm

Rock Town Distillery, Inc.

Sold / distributed

Distributed in Arkansas USA

Why it was recalled

CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification 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

ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solution packaged in a) 375 mL (12.7 fl. oz.), NDC 74492-0002-1; b) 3785 mL/1 gallon NDC 74492-0002-2; c) 236 mL/8 oz. NDC 74492-0002-3; d) 473 mL/16 oz. NDC 74492-0002-4; Made in USA Rock Town Distillery, 1201 Main Street Little Rock, Arkansas 72202