The Recall Desk
ModerateFDA (Drugs)·D-0715-2022·Announced 2022-03-30

Rock Town Distillery Hand Sanitizer Recall Due to Chemical Contamination

Rock Town Distillery is recalling hand sanitizer products distributed in Arkansas due to FDA findings of acetal and acetaldehyde above specification limits resulting from manufacturing deviations.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall for a drug product with manufacturing deviations. The source text does not report any illnesses, injuries, or deaths, and the hazard is a specification exceedance rather than a confirmed safety threat. Per the rubric, Class II recalls without reported harm and with no imminent serious health risk typically score 2 (Moderate).

Plain-English summary

Rock Town Distillery, Inc. is recalling ROCK TOWN DISTILLERY HAND SANITIZER, an Alcohol Antiseptic 70% topical solution, distributed in Arkansas. The recall affects four package sizes: 236 mL (8 oz., NDC 74492-0002-3), 375 mL (12.7 fl. oz., NDC 74492-0002-1), 473 mL (16 oz., NDC 74492-0002-4), and 3785 mL (1 gallon, NDC 74492-0002-2). Approximately 35,468 containers are affected.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA analysis found that the product contains acetal and acetaldehyde at levels above specification limits.

Consumers who have purchased this hand sanitizer should stop using it. Persons with questions may contact Rock Town Distillery at their facility located at 1201 Main Street, Little Rock, Arkansas 72202.

The recalled product

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,
Manufacturer
Rock Town Distillery, Inc.
Category
Drug — Hand Sanitizer
Hazard
  • chemical-contamination
  • manufacturing-deviation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • No lot number or expiration date.

Distribution

Distribution scope not specified by the agency.

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