- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Reason for Announcement:
Recall Reason DescriptionUndeclared methanol
- Company Name:
- Real Clean Distribuciones SA de CV
- Brand Name:
Brand Name(s)Born Basic, Scent Theory and more
- Product Description:
Product DescriptionHand Sanitizer
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.
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:
- Toll Free: 866-512-4073
- FAX: 844-294-7183
- Email: Realclean4107@stericycle.com
- Event: 4107
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.
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