Safety Report: Born Basic, Scent Theory and other brands Hand Sanitizer - recalled due to Undeclared methanol, USA

United States

Company name: Real Clean Distribuciones SA de CV
Brand name: Born Basic, Scent Theory and more
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared methanol
FDA Recall date: July 24, 2020
Recall details: La Loma, Tlalnepantla, Mexico, Real Clean Distribuciones SA de CV is voluntarily recalling all lots it manufactured within expiry of the following brand names of hand sanitizers:
- Born Basic ANTI-BAC HAND SANITIZER
- Scent Theory KEEP CLEAN Moisturizing Hand Sanitizer
- Scent Theory KEEP IT CLEAN Moisturizing Hand Sanitizer
- Lux Eoi Hand Sanitizing Gel to the consumer level.

The products are being recalled due to the potential presence of methanol (wood alcohol).

Risk Statement: Substantial methanol exposure could 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 these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. To date, Real Clean Distribuciones SA de CV has not received reports of adverse events related to this recall.

RECALLED PRODUCTS These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. Real Clean Distribuciones SA de CV manufacturers product for four brands included in this recall. Scent Theory and Born Basic hand sanitizer products are produced by several different manufacturers, in several different countries, and only those lots manufactured by Real Clean in Mexico are subject to the recall. The recalled products include the following lots:

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Scent Theory Keep Clean Hand Sanitizer 70% Alcohol
Country of Origin: Mexico
Size: 16.9oz
Lot Numbers: 1633220, 1733220, 1833220, 1933220, 2033220, 2133220, 2233220, 2333220, 2433220, 2533220, 2633220, 2733220, 2833220, 2933220, 3033220, 3133220, 3233220, 3333220, 3433220, 3533220, 3633220, 3733220, 3833220, 3933220, 4033220, 4133220

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Keep it Clean Hand Sanitizer 70% Alcohol
Country of Origin: Mexico
Size: 16.9oz
Lot Numbers: 0133220, 0233220, 0333220, 0433220, 0533220, 0633220, 0733220, 0833220, 0933220, 1033220 1133220, 1233220, 1333220, 1433220, 1533220

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Born Basic Anti-Bac Hand Sanitizer 70% Alcohol
Country of Origin: Mexico
Size: 16.9oz
Lot Numbers: 0833420, 0933420, 1033420, 1133420, 1233420, 1333420, 1433420, 1533420, 1633420, 1733420, 1833420, 1933420, 2033420, 2133420, 2233420, 2333420, 2433420, 2533420, 2633420, 2733420, 2833420, 2933420

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Born Basic Anti-Bac Hand Sanitizer 70% Alcohol
Country of Origin: Mexico
Size: 34oz
Lot Numbers: 0133420, 0233420, 0333420, 0433420, 0533420, 0633420

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Born Basic Anti-Bac Hand Sanitizer 70% Alcohol
Country of Origin: Mexico
Size: 9.5oz
Lot Numbers: 0133720, 0233720

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Lux Eoi Hand Sanitizing Gel
Country of Origin: Mexico
Size: 16.9oz
Lot Numbers: 0133920, 0233920, 0333920

Real Clean Distribuciones SA de CV is notifying its distributors by recall letter and consumers via this press release. Real Clean Distribuciones SA de CV is arranging for the return and refund of all recalled products.

Consumers/distributors/retailers that have the product subject to this recall should stop using/distributing/selling Hand Sanitizer and return it to the place of purchase; because the affected products are considered hazardous materials, do not destroy the affected products.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/real-clean-distribuciones-sa-de-cv-issues-voluntary-nationwide-recall-four-hand-sanitizer-due

Source: FDA