Highest risk U.S. Food and Drug Administration

Harmonic Nature Hand sanitizer recall: Product contains 1 propanol

Recall published 6+ years ago

Product contains 1 propanol

The hazard: Drug safety concern

The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Published
August 14, 2020
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Harmonic Nature
Product type
Prescription & OTC drugs
UPC codes
7500462892210

Products covered by this recall

Hand sanitizer

What the company announced

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 [email protected] 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.

CDER’s press statement

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 7500462892210

Package size

Match the net weight or the piece count on the front of the pack.

  • 250 mL

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Harmonic Nature — The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.

  1. Check the lot number on your pack against the codes listed above.
  2. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
  3. Ask the dispensing pharmacy for a replacement from an unaffected lot.
  4. Keep the carton; the lot number is often printed only on the outer pack.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: HARMONIC NATURE S. DE R.L. Mi — Consumers: Harmonic Nature, +52 8120 2967 03, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Harmonic Nature prescription & otc drugs recalled?

Product contains 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 7500462892210. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

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