ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solution packaged in a) 375 mL (12.7 fl. oz.),
Summary
The FDA issued a Class II for ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solutio by Rock Town Distillery, Inc.. Reason: CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits..
Details
Source
Drug Recall
External ID
D-0715-2022
Action Date
2022-03-30
Status
Terminated
Category
drug
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
Lot/Code Info: No lot number or expiration date.
Quantity Affected: 35,468 containers
Reason for Recall
CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
Distribution
Distributed in Arkansas USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-10
Company
Little Rock, AR
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 78 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Rock Town Distillery, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Rock Town Distillery, Inc. have FDA actions?
This is the only FDA action we have on record for Rock Town Distillery, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0715-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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