Health Canada
Health Canada Recall
SunnaPure Hand Sanitizer Spray (NPN# 80099057), 60mL Lots 0620-1, 0620-2, 0620-3 and 0620-4 EXP 06/2022
These affected lots were shipped July 8, 2020 – August 30, 2020.
The above noted product and subsequent lots have been deemed by Health Canada as a Type II Health Risk which is defined as ‘a situation in which the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote’.
It is deemed this because we were was sold misrepresented grade ethanol. They were sold ‘Food Chemical Codex (FCC)-grade ethanol’ from a supplier which Health Canada is deeming to be Technical Grade Ethanol.
Health Canada had not yet recognized the manufacturer of the ethanol to produce Food Chemical Codex (FCC)-grade ethanol at the time the allocated lot of ethanol was used to make the above noted lots.
It is being recalled because labels did not observe additional risk statements required for technical grade ethanol.
How did this happen?
We put every process in place in ensure we were using FCC grade ethanol. We even had drums of technical grade ethanol returned when we first received it from our supplier, prior to making these first batches in June 2020. The supplier took our return and replaced it with "FCC grade ethanol." Unfortunately, the supplier sold us unauthorized food grade ethanol after receiving third party tested against the FCC requirements. The Certificate of Analysis (COA) we received with the shipment showed it being in-line with FCC grade ethanol. Health Canada reached out to us because the manufacturer of the ethanol was not yet approved by Health Canada to produce FCC grade.
It is being recalled because labels did not observe additional risk statements required for technical grade ethanol.
What about current/newer lots?
Since production of the lots in question (June 2020), they have removed the supplier from the supply chain and are working directly with the approved manufacturer of FCC Grade Ethanol. They only contain FCC grade ethanol.
The was only 38 days of shipments of the lots in question from July 8, 2020 – August 30, 2020.
What if I have these lots now?
It has been almost a year since we have shipped these orders, if you still have any of the lots listed above, please contact us: sales@cosmeticsbykatakami.com