ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solution packaged in a)...
FDA Recall #D-0715-2022 — Class II — March 10, 2022
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
Reason for Recall
CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
Recalling Firm
Rock Town Distillery, Inc. — Little Rock, AR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
35,468 containers
Distribution
Distributed in Arkansas USA
Code Information
No lot number or expiration date.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.