FDA recall D-0715-2022

Product

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

Reason for recall

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

Distribution

Distributed in Arkansas USA

Key facts

Status

Terminated

Initiation date

2022-03-10

Report date

2022-03-30

Termination date

2023-08-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0715-2022