Public advisory

Incorrect dosing information on the “SAVE ME” instructional card in the Naloxone Take Home Kit by Canadian Hospital Specialties Ltd

Last updated

Summary

Product
Naloxone Take Home Kits by Canadian Hospital Specialties Ltd.
Issue
Health products - New safety information
What to do

Check to see if your Naloxone Take Home Kit is impacted. If yes, contact the company or the store from which you obtained it to receive a new “SAVE ME” instructional card. If you need to administer a second dose of naloxone, you can safely do so two to three minutes after the first dose. 

Affected products

Naloxone Take Home Kits by Canadian Hospital Specialties Ltd.

Issue

Naloxone Take Home Kits (NTH Kits) by Canadian Hospital Specialties Ltd. may contain incorrect naloxone dosing information on the “SAVE ME” instructional card, which could impact the efficacy of the treatment.

The product labelling for naloxone indicates that, if necessary, a second dose of the product can be administered two to three minutes after the first dose. The "SAVE ME" instructional card provided in the kit may recommend re-administration after three to five minutes. This is an error. Any “SAVE ME” instructional card that differs from the two to three-minute dosing re-administration recommendation that is found within the NTH Kits should be returned to the company or the store in order to obtain a corrected “SAVE ME” instructional card. Delaying the administration of an additional dose may result in permanent disability or death.

The NTH Kits contain naloxone either as a nasal spray, an ampule (injectable), or a vial (injectable). These products are used to reverse the effects of opioid overdose.

Anyone with an impacted NTH Kit should contact the company at recalls@chsltd.com or the store where they obtained it to request a revised "SAVE ME" instructional card with the correct information.

It is important to note that these NTH Kits are not being removed from the Canadian market so as not to disrupt access to naloxone, a potentially life-saving drug.

Health Canada is monitoring the situation and if additional safety information is identified, it will take appropriate action and inform Canadians, as needed.

What you should do

  • If you need to administer a second dose of naloxone, you can safely do so two to three minutes after the first dose.
  • Check to see if your NTH Kit is impacted. If yes, contact the company at recalls@chsltd.com or the store from which you obtained it to receive a new “SAVE ME” instructional card.
  • Report any health product-related side effects or complaints to Health Canada.

Additional information

Details
Original published date:
Alert / recall type
Public advisory
Category
Health products - Medical devices
Companies
Published by
Health Canada
Audience
Identification number
RA-75874
Media and public enquiries

Media Enquiries:

Health Canada

(613) 957-2983

media@hc-sc.gc.ca

Public Enquiries:

(613) 957-2991

1-866 225-0709

info@hc-sc.gc.ca

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