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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Over-the-Counter

Grato Holdings, Inc.: Colostat Homeopathic Remedy Recalled for Incorrect Label Indications

Agency Publication Date: March 20, 2020
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Summary

Grato Holdings, Inc. is recalling approximately 659 bottles of Colostat, a homeopathic remedy distributed by Energique, Inc. The recall was initiated because of a labeling mix-up where the indications for use printed on the product label are incorrect. Consumers should check for 1 fl. oz. (30 mL) bottles labeled with lot number Z56673. Because this is a medication recall with incorrect labeling information, you should consult with a healthcare professional regarding any concerns about its use.

Risk

The incorrect indications on the label may lead consumers to use the product for purposes other than intended or in a manner that is not appropriate for their symptoms. This labeling error poses a low risk but could result in improper self-treatment.

What You Should Do

  1. Check your medicine cabinet for Colostat Homeopathic Remedy in 1 fl. oz. (30 mL) bottles with NDC number 44911-0411-1.
  2. Specifically look for lot number Z56673 printed on the product packaging.
  3. If you have an affected bottle, contact your healthcare provider or pharmacist for guidance regarding its use and your specific health needs.
  4. Return any unused product to the place of purchase for a refund.
  5. Contact Grato Holdings, Inc. or the distributor Energique, Inc. at their Woodbine, Iowa location for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund for incorrectly labeled medication

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Colostat, Homeopathic Remedy (1 fl. oz. / 30 mL)
Model:
NDC 44911-0411-1
Lot Numbers:
Z56673

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85072
Status: Resolved
Manufacturer: Grato Holdings, Inc.
Sold By: Energique, Inc.
Manufactured In: United States
Units Affected: 659 bottles
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.