FDA Recalls Colostat Homeopathic Remedy Due to Incorrect Labeling
Grato Holdings, Inc. is recalling 659 bottles of Colostat homeopathic remedy because the indications on the product label are incorrect.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classifies this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard is limited to incorrect labeling (documentation issue) with no reported injuries or illnesses.
Plain-English summary
Grato Holdings, Inc. is recalling 659 bottles of Colostat, a homeopathic remedy, due to a labeling error. The product is a 1 fl. oz. (30 mL) bottle containing 20% ethanol and is distributed by Energique, Inc. The specific lot affected is # Z56673.
The recall was initiated because the indications listed on the product label are incorrect. This is a labeling mix-up rather than a contamination or manufacturing defect in the liquid itself. The product was distributed nationwide in the U.S.A. and in Israel.
Consumers who have purchased this specific lot of Colostat should stop using it and return it to the point of purchase for a refund or contact the recalling firm for further instructions. The FDA classifies this as a Class III recall, indicating that the product is not likely to cause adverse health consequences.
The recalled product
- Product
- COLOSTAT (RHAMNUS PURSHIANA, SPIGELIA ANTHELMIA, TARAXACUM OFFICINALE, CAJUPUTUM, HYDRASTIS CANADENSIS, ALUMINA, CINA, CINCHONA OFFICINALIS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, MANDRAGORA OFFICINARUM, NUX VOMICA)
- Brand
- COLOSTAT
- Manufacturer
- Grato Holdings, Inc.
- Category
- Drug — Homeopathic Remedy
- Hazard
- Affected units
- 659
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # Z56673
UPCs (1)
- 0363113700084
Distribution
Distributed nationwide across the United States.
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