D-0715-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 30, 2022
- Initiation Date
- March 10, 2022
- Termination Date
- August 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,468 containers
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.
Distribution Pattern
Distributed in Arkansas USA
Code Information
No lot number or expiration date.