summary

Company announcement date:
FDA Release Date:
Type of product:
Drugs
Reason for listing:

Reason for recall Description

Packaged in bottles that look like beverage containers

Company Name:
Ardil Commercial
Mark:
Product Description:

Company announcement

Santo Domingo, Dominican Republic – Ardil Comercial is voluntarily recalling a batch of Limar hand sanitizer, packaged in 4 oz bottles at the consumer level. The hand sanitizer is being recalled because it is packaged in containers that look like water bottles. The product presents a risk of ingestion.

Ingestion of hand sanitizer, which is intended for topical use, could potentially result in alcohol toxicity. Symptoms of alcohol toxicity can range from poor coordination, slowed down or cloudy speech, drowsiness to coma, which can be fatal. In addition, ingestion of alcohol can affect the brain and result in impaired driving or the use of heavy machinery. Alcohol can also interact with many drugs, which can lead to serious side effects. Ingestion of alcohol by people addicted to alcohol may interfere with the maintenance of abstinence. Additionally, people addicted to alcohol may seek out large amounts of ethanol-based hand sanitizers as a substitute. To date, Ardil Comercial has not received any reports of adverse events related to this recall.

The product is intended to be applied topically to help reduce bacteria on the skin that could cause disease when soap and water are not available and is packaged in 4 oz bottles. under the Limar brand. The product can be identified by the bottle labels shown below. The affected product lots include the following lot number: 079932-4611-05-J with the following expiration date: May 2022. Limar 4 oz Hand Sanitizer has been distributed nationally to a distributor who may have subsequently been distributed in the United States.

Ardil Comercial informs its distributors and customers by phone, press release and arrange for a substitute of all recalled products. Consumers and distributors who have the recalled product must return to the place of purchase.

Consumers with questions regarding this recall can contact Ardil Comercial at 809-231-2583, ext. 9 or administracion@ardilcomercial.com Monday through Friday 8 a.m. to 5 p.m. AST. Consumers should contact their doctor or health care provider if they have had any problems that may be related to taking or using this medication.

Adverse reactions or quality issues encountered while using this product can be reported to the FDA’s MedWatch Adverse Event Reporting Program, online by regular mail or by fax.

  • Complete and submit the report online
  • Regular Mail or Fax: Download the form or call 1-800-332-1088 to request a report form, then complete and return it to the address on the pre-addressed form, or fax it to 1-800-FDA-0178

This recall is being made with the knowledge of the United States Food and Drug Administration.


Company details


Product Pictures