Real Clean Distribuciones SA de CV Issues Voluntary Nationwide Recall of Four Hand Sanitizer Due to Potential Presence of Undeclared Methanol (Wood Alcohol)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Undeclared methanol
Company Name:
Real Clean Distribuciones SA de CV
Brand Name:
Born Basic, Scent Theory and more
Product Description:
Hand Sanitizer

Company Announcement

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, and
  • 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 Product Country of Origin Size Lot Numbers
Real Clean Distribuciones S.A. De C.V. Scent Theory Keep Clean Hand Sanitizer 70% Alcohol Mexico 16.9oz 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
Real Clean Distribuciones S.A. De C.V. Keep it Clean Hand Sanitizer 70% Alcohol Mexico 16.9oz 0133220, 0233220, 0333220, 0433220, 0533220, 0633220, 0733220, 0833220, 0933220, 1033220 1133220, 1233220, 1333220, 1433220, 1533220
Real Clean Distribuciones S.A. De C.V. Born Basic Anti-Bac Hand Sanitizer 70% Alcohol Mexico 16.9oz 0833420, 0933420, 1033420, 1133420, 1233420, 1333420, 1433420, 1533420, 1633420, 1733420, 1833420, 1933420, 2033420, 2133420, 2233420, 2333420, 2433420, 2533420, 2633420, 2733420, 2833420, 2933420
Real Clean Distribuciones S.A. De C.V. Born Basic Anti-Bac Hand Sanitizer 70% Alcohol Mexico 34oz 0133420, 0233420, 0333420, 0433420, 0533420, 0633420
Real Clean Distribuciones S.A. De C.V. Born Basic Anti-Bac Hand Sanitizer 70% Alcohol Mexico 9.5oz 0133720, 0233720
Real Clean Distribuciones S.A. De C.V. Lux Eoi Hand Sanitizing Gel Mexico 16.9oz 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.

Consumers with questions regarding this recall can contact Stericycle during the following hours: Sunday – Saturday 08:00 am – 8:00 pm EST at:

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.

Link to FDA’s update


Company Contact Information

Consumers:
Stericycle
 866-512-4073
 Realclean4107@stericycle.com