CLASS III Drug recall · Reported 1 Apr 2020 · FDA Enforcement Report
Colostat, Homeopathic Remedy per, 20% Ethanol recalled by Grato Holdings
Grato Holdings is recalling Colostat, Homeopathic Remedy per, 20% Ethanol, distributed nationwide in the US. The recall was initiated on 15 Nov 2019 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1049-2020
- FDA event ID
- 85072
- Recalling firm
- Grato Holdings, Woodbine, IA
- Brand
- Colostat
- Manufacturer
- Energique, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Nov 2019
- FDA classified
- 20 Mar 2020
- Reported
- 1 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 15 Nov 2019 | Recall initiated by company | |
| 20 Mar 2020 | Classified by FDA | +126 days |
| 1 Apr 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling mix-up - Indications on product label are incorrect.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
U.S.A. Nationwide, Israel
Questions about this recall
Why was it recalled?
Labeling mix-up - Indications on product label are incorrect.
Which lots are affected?
Lot # Z56673
Where was it sold?
U.S.A. Nationwide, Israel
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 30 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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