Recall D-0715-2022
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
Recall D-0715-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0715-2022 |
Event ID | 89774 |
Distribution | Distributed in Arkansas USA |
Quantity | 35,468 containers |
Recall Reason | CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits. |
Drug Classification | Class II |
Drug Code Info | 20220330 |
Recall Initiation Date | 20220310 |
Report Date | 20220330 |
Classification Date | 20220323 |
Address | 1201 Main St Little Rock, AR 72202-5031 United States |
Recalling Firm | Rock Town Distillery, Inc. |
Initial Notification | Other |
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