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August 29, 2020 from the FDA
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.
These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available.
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 |
NDC |
Size |
UPC |
Lot |
---|---|---|---|---|
Always Be Clean hand sanitizer | 75091-2020-1 75091-2020-2 75091-2020-3 |
Single snaps 100 Count 25 Count |
375091202016 375091202023 375091202030 |
ES8-200514 |
Just Hand Sanitizer | 78065-2020-1 78065-2020-2 |
Single Snaps 100 Count |
703123998659 703123998598 |
ES9-200610 |
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 handsanitizer@openbookextracts.com or 917-536-1194 (9 a.m.- 5 p.m. ET) to replace the hand sanitizer free of charge.
The information posted is from secondary sources. We cannot take responsibility for the accuracy of the information. |
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