Product Safety Recalls

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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0715-2022
Event ID89774
DistributionDistributed in Arkansas USA
Quantity35,468 containers
Recall ReasonCGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
Drug ClassificationClass II
Drug Code Info20220330
Recall Initiation Date20220310
Report Date20220330
Classification Date20220323
Address1201 Main St
Little Rock, AR 72202-5031
United States
Recalling FirmRock Town Distillery, Inc.
Initial Notification Other
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