CLASS II Drug recall · Reported 30 Mar 2022 · FDA Enforcement Report
Hand Sanitizer, Alcohol Antiseptic 70%, Topical Solution recalled
Rock Town Distillery is recalling Hand Sanitizer, Alcohol Antiseptic 70%, Topical Solution, distributed in Arkansas. The recall was initiated on 10 Mar 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0715-2022
- FDA event ID
- 89774
- Recalling firm
- Rock Town Distillery, Little Rock, AR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Mar 2022
- FDA classified
- 23 Mar 2022
- Reported
- 30 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 10 Mar 2022 | Recall initiated by company | |
| 23 Mar 2022 | Classified by FDA | +13 days |
| 30 Mar 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
Product as listed by the FDA
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
Where it was distributed
Distributed in Arkansas USA
Questions about this recall
Why was it recalled?
CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
Which lots are affected?
No lot number or expiration date.
Where was it sold?
Distributed in Arkansas USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Hand Sanitizer recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution recalled | Fisher Scientific | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Hand Sanitizer (60%), Non-Sterile Solution recalled by Walker Emulsions | Walker Emulsions | Labeling Errors | OR, SC |