Colostat Liquid
FDA Recall NDC 44911-0411
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Colostat (NDC 44911-0411). A significant event, classified as Class III, was initiated on Nov 15, 2019 by Energique, Inc.. The reported reason for this action was: "Labeling mix-up - Indications on product label are incorrect."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
November 2019 Class III Recall: Labeling mix-up - Indications on product label are incorrect.
Recall Number
Class III Terminated
Labeling mix-up - Indications on product label are incorrect.
Nov 15, 2019
Apr 01, 2020
659 bottles
Recall Profile & Regulatory Data
Event ID
85072
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Grato Holdings, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide, Israel
Termination Date
Sep 28, 2020
Product Description
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
44911-0411-1Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
