COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Read AnnouncementSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
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Recall Reason Description
Product contains 1 propanol
- Company Name:
- HARMONIC NATURE S. DE R.L. Mi
- Brand Name:
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Brand Name(s)
- Product Description:
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Product Description
Company Announcement
Guadalupe, Nuevo Leon, Harmonic Nature is voluntarily recalling all 800 bottles Hand Sanitizer, 250mL, product due to the potential presence of 1-propanol. The products have been tested and found to contain 1 propanol.
Risk Statement: Any amount of 1-propanol with a concentration greater than or equal to 1% by volume that is unlisted in a product labeled as an ethanol-based hand sanitizer has a reasonable probability of acute toxicity from ingestion which can cause central nervous system depression, which could result in death, permanent impairment, or necessitate medical or surgical intervention. Populations most at risk include individual with alcohol addiction and adolescents, who have been known to ingest ethanol-based antiseptic rubs intentionally to become intoxicated, as well as infants and children who may unintentionally ingest the defective product. Harmonic Nature has not received any reports of adverse events related to this recall.
The product is used as a hand sanitizer and is packaged in 250 mL plastic bottles , with UPC Code 7500462892210. The product can be identified by Harmonic Nature as a hand sanitizer Topical Solution distributed only to and currently on hold at the US custom bróker, Aquiles INC.
Harmonic Nature is notifying Aquiles INC. and is arranging for return of all recalled product. Consumers with questions regarding this recall can contact Harmonic Nature by +(52) 8120 2967 03 or miguel_martinez2000@yahoo.com Monday to Friday from 8:00 am to 6:00pm central time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
