Rock Town Distillery, Inc.: Drug Recall

Recall #D-0715-2022 · 03/10/2022

Class II: Risk

Recall Details

Recall Number
D-0715-2022
Classification
Class II
Product Type
Drug
Recalling Firm
Rock Town Distillery, Inc.
Status
Terminated
Date Initiated
03/10/2022
Location
Little Rock, AR, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
35,468 containers

Reason for Recall

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

Product Description

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

Distribution Pattern

Distributed in Arkansas USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.