March 2022 FDA Recall Drug by Rock Town Distillery, Inc.
D-0715-2022 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Rock Town Distillery, Inc. on March 10, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Distributed in Arkansas USA and the recall is currently terminated.

Recall Number: D-0715-2022

Reason for Recall
CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
Initiated
03-10-2022
Reported
03-30-2022
Quantity
35,468 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89774
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Rock Town Distillery, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Other
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in Arkansas USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-23-2023
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# No lot number or expiration date.