FDA-Drug2020-04-01Class III

Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist. by Energique, Inc., 201 Apple Blvd., Woodbine, IA 51579, NDC 44911-0411-1

Grato Holdings, Inc.
Hazard

Labeling mix-up - Indications on product label are incorrect.

Sold states
U.S.A. Nationwide, Israel
Affected count
659 bottles
Manufactured in
201 Apple Blvd, N/A, Woodbine, IA, United States
Products
Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist. by Energique, Inc., 201 Apple Blvd., Woodbine, IA 51579, NDC 44911-0411-1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1049-2020

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