- Company Announcement Date:
- June 26, 2020
- FDA Publish Date:
- June 27, 2020
- Product Type:
- Reason for Announcement:
Recall Reason Description
May contain methanol (wood alcohol)
- Company Name:
- Saniderm Products
- Brand Name:
- Product Description:
Advanced Hand Sanitizer
Saniderm Products (Saniderm) is voluntarily recalling Saniderm Advanced Hand Sanitizer, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). In response to a recent news alert by the Food and Drug Administration advising consumers of potentially toxic hand sanitizer manufactured by Eskbiochem SA de CV in Mexico, Saniderm has proactively taken necessary precautions to ensure the safety of consumers.
Out of an abundance of caution, Saniderm has initiated a voluntary recall of all products produced by Eskbiochem SA de CV with a “Made in Mexico” origin.
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, Saniderm has not received any reports of adverse events related to the product in question.
The product is a hand sanitizer and is packaged in 1-liter plastic bottles with an orange twist-top cap. The affected Sandiderm Advanced Hand Sanitizer include lot number 53131626, manufactured date April/1/20, clear bottle that can be further distinguished by looking at the back side label and identifying “Made in Mexico” and “Produced by: Eskbiochem SA de CV”. No other bottles distributed by Saniderm match the description above, hence all products as described above are subject to the voluntary recall. The product can be identified by the photos below. The product was distributed in Virginia, Maryland, and New Jersey on April 15,2020.
Saniderm is notifying its distributors and customers by email and is arranging for the handling of all voluntary recalled products. All individuals that have the bottle in question should immediately stop using and contact Saniderm for guidance on the return and disposal of the product.
Consumers with questions regarding this voluntary recall can contact Saniderm at +1 (415) 562-5502 or [email protected] from Monday-Friday 9am-6pm, PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug 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.
- 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.