Hand Sanitizer Recall: Wood Alcohol Contaminant

Summary

Company Announcement Date:
December 23, 2020
FDA Publish Date:
December 23, 2020
Product Type:
Drugs
Reason for Announcement:
Undeclared Methanol
Company Name:
Shane Erickson, Inc. DBA Innovative Marketing Consultants
Brand Name:
IMC
Product Description:
Wash-Free Hand Sanitizer

Company Announcement

Shane Erickson, Inc. is voluntarily recalling lot 2020/05/11 and MFG: 2020/05/10 L/N: 20200510-3 of imc Wash-Free Hand Sanitizer 50 ml, 100 ml, 300 ml and Wash Free Hand Sanitizer 300 ml lot 2020/05/11 and Thrifty White Pharmacy Wash-Free Hand Sanitizer 300 ml lot 2020/05/11 listed in the table below to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

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 these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. To date, Shane Erickson, Inc. has not received any reports of adverse events related to the product(s) of this recall.

Recalled Products:

Product Name Size UPC Lot Expiration date
imc Wash-Free Hand Sanitizer 50 ml, 1.7 oz 8 19845 00597 8 2020/05/11 2023/05/10
imc Wash-Free Hand Sanitizer 100 ml, 3.4 oz 8 19845 00598 5 MFG: 2020/05/10 L/N: 20200510-3 N/A
imc Wash-Free Hand Sanitizer 300 ml, 10.14 oz 8 19845 00599 2 2020/05/11 2023/05/10
Wash-Free Hand Sanitizer
Thrifty White Pharmacy Wash-Free Hand Sanitizer

Please see label examples for all sizes below.

The product is used as a hand sanitizer for handwashing to decrease bacteria on the skin when soap and water are not available. All products are packaged in a plastic bottle. The 50 ml are in a HDPE opaque white bottle with a blue cap, the 100 ml is in a clear PET bottle with a clear cap and the 300 ml are in a clear PET bottle with a black pump. The product can be identified by checking the product size, UPC details, lot number and expiration date on the bottle containing the product. The product can also be identified by this information on the back label: Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384, YUEWEIXIAOZHENGZI (2020) Р04 РNo. 0023.  Some of the product has custom front labels (see examples below) the back label on the custom labels have the same identification information as previously mentioned above. The hand sanitizer was distributed Nationwide in the USA to wholesale and retail customers.

Read the full report here.
As published by the FDA on HealthyExaminer.com