- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Reason for Announcement:
Recall Reason Description
Products labeled to contain methanol
- Company Name:
- Open Book Extracts
- Brand Name:
Always Be Clean, Just
- Product Description:
Open Book Extracts (OBX) is voluntarily recalling to the consumer level all lots of Always Be Clean Hand Sanitizer and Just Hand Sanitizer that are labeled to contain methanol.
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.
OBX sources hand sanitizer from a leading global chemical and ingredient distributor, and has verified through a third-party lab that the hand sanitizer does not contain reportable levels of methanol. The supplier updated the Safety Data Sheet (SDS) to remove methanol since it is below the reportable level, and we updated the labels accordingly.
These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available.
The mislabeled hand sanitizer was packaged in single-use packets and multi-count boxes using the following NDC and Lot codes:
Name of Product
|Always Be Clean hand sanitizer||75091-2020-1|
|Just Hand Sanitizer||78065-2020-1|
The mislabeled hand sanitizer was packaged from May 14, 2020 through June 1, 2020 and sold from May 15, 2020 through July 16, 2020 Nationwide in the USA to businesses for internal use.
OBX has notified all distributors via phone and email and is replacing all of the mislabeled product. While OBX believes that all mislabeled units have been recovered or, in the case of Just Hand Sanitizer, were relabeled prior to sale, anyone with questions regarding this recall or are in possession of Just Hand Sanitizer or Always Be Clean Hand Sanitizer from the above-listed lots that list methanol as an inactive ingredient may contact Open Book Extracts at [email protected] or 917-536-1194 (9 a.m.- 5 p.m. ET) to replace the hand sanitizer free of charge.
Distributors or businesses that have product labeled to contain methanol should stop distribution and return to place of purchase. 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.
Link to FDA Update