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Recall Observatory FDA recall evidence

Drug 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

D-1561-2020

August 03, 2020

Class II

Product summary

Firm
Leiper's Fork Distillery
Event
Event 86182
Status
Terminated
Classification
Class II
Quantity
1996 gallons
Official record key
drug-enforcement:D-1561-2020

Official wording

Reason: Labeling Not Elsewhere Classified: Product labeled to contain methanol.

Code information: All Lots

Distribution pattern: TN

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    contain methanol