August 2020 FDA Recall Drug by Leiper's Fork Distillery
D-1561-2020 - Labeling Not Elsewhere Classified

This Class II drug recall was voluntarily initiated by Leiper's Fork Distillery on August 3, 2020 for the product Drug. The FDA reported the reason for recall as labeling not elsewhere classified. The product was distributed in TN and the recall is currently terminated.

Recall Number: D-1561-2020

Reason for Recall
Labeling Not Elsewhere Classified: Product labeled to contain methanol.
Initiated
08-03-2020
Reported
09-09-2020
Quantity
1996 gallons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86182
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Leiper's Fork Distillery
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
TN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-22-2022
Product Description About Product Description
Full technical description of the product.
Leiper's Fork Distillery, Alcohol Antiseptic Topical Solution, Ethyl Alcohol 70%, packaged as a) 16 fluid oz./473.18 mL, bottle. b) 5 gallon vacuum sealed bucket. Leiper's Fork Distillery

Batch or Lot Expiration Information

Lot# All Lots