Safety Report: DIBAR Labs, ProtectoRx Hand Sanitizer - recalled due to presence of methanol, USA

United States

Company name: Dibar Nutricional S. de R.L. de C.V.
Brand name: DIBAR Labs, ProtectoRx
Product recalled: Hand Sanitizer
Reason of the recall: Presence of methanol
FDA Recall date: May 19, 2021
Recall details: Morelia, Michoacán, Mexico, Dibar Nutricional S. de R.L. De C.V. (“Dibar”) is voluntarily recalling all Dibar Labs Hand Sanitizer packaged in 8oz and 16 oz bottles, respectively, to the consumer level (see Label 1 below). Dibar is also voluntarily recalling ProtectoRx Hand Sanitizer packaged in 2oz and 16oz fluid ounce bottles, respectively, to the consumer level (see Label 2 below), as well as all Advance Hand Sanitizer packaged in 16 oz bottles, likewise, to the consumer level (see Label 3 below). These products are being recalled after testing conducted by our firm revealed the presence of methanol.

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest the products and adolescents and adults who drink the products as an alcohol (ethanol) substitute are most at risk for methanol poisoning.

To date, the company has not received any reports of adverse reactions related to this recall. These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available.

The affected bottles of hand sanitizer include a twelvedigit lot code printed on the bottle near the base. The products can be identified by the label image provided at the end of this release. Products labeled as Dibar Labs Hand Sanitizer were distributed nationwide in the USA through S.E.N.D. LLC and its customers. Products labeled as ProtectoRx Hand Sanitizer were distributed in Puerto Rico through PR TRADING LLC and its customers. Products labeled as Advance Hand Sanitizer were distributed in the USA through RGV HEALTH SERVICES LLC DBA VALLEY and its customers.

Dibar Nutricional S. de R.L. De C.V., has notified its direct distributors by letter and asked that they remove the recalled products from commerce immediately if they still possess inventory.

Consumers, distributors and retailers that have the hand sanitizers which are being recalled should stop using, distributing and/or selling them and return them to the place of purchase. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Link to Original Recall

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dibar-nutricional-s-de-rl-de-cv-issues-voluntary-nationwide-expanded-recall-dibar-labs-hand

Source: FDA