November 2019 FDA Recall Colostat by Grato Holdings, Inc.
D-1049-2020 - Labeling mix-up - Indications on product label are incorrect.

This Class III drug recall was voluntarily initiated by Grato Holdings, Inc. on November 15, 2019 for the product Colostat. The FDA reported the reason for recall as labeling mix-up - indications on product label are incorrect.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1049-2020

Reason for Recall
Labeling mix-up - Indications on product label are incorrect.
Initiated
11-15-2019
Reported
04-01-2020
Quantity
659 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85072
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Grato Holdings, Inc.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide, Israel
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-28-2020
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Z56673

Affected Packages Involved in this Recall

44911-0411-1 Colostat