Health Canada warns of dosing instruction error in naloxone take-home kits

Health Canada warns that  naloxone take-home kits (NTH kits) by Canadian Hospital Specialties Ltd. may contain incorrect naloxone dosing information on the “save me” instructional card.

Following those instructions could impact the efficacy of the treatment when using the kits to reverse the effects of opioid overdose, Health Canada says in an announcement Friday.

The NTH Kits contain naloxone either as a nasal spray, an ampule (injectable) or a vial (injectable).

The product labelling for naloxone should indicate a second dose of the product can be administered two to three minutes after the first dose if necessary.

However, the instructional card provided in the kit may recommend re-administration after three to five minutes. This is an error. 

Any instructional card that differs from the two- to three-minute dosing re-administration recommendation should be returned to the company or the store in order to obtain a corrected card, the announcement says.

“Delaying the administration of an additional dose may result in permanent disability or death,” it says.

Anyone who discovers their NTH Kit has erroneous instructions should contact the company at recalls@chsltd.com or the store where they purchased it in order to receive a corrected instructional card.

The kits are not being removed from the market so as to not disrupt access to naloxone, Health Canada says, noting it is monitoring the situation.