Public advisory

JAMP Guanfacine XR 1 mg tablets: One lot recalled as some bottles may also contain higher strength tablets

Last updated

Summary

Product
JAMP Guanfacine XR 1 mg tablets
Issue
Health products - Product safety
What to do

Check your or your child's pill bottle to ensure it contains only white, round JAMP Guanfacine XR 1 mg tablets. If it contains any green, oval JAMP Guanfacine XR 4 mg tablets, or if you are unsure, return it to your pharmacy. Your pharmacist will check it and provide you with a replacement if needed. Contact a health care professional immediately if you or your child are experiencing signs and symptoms of overdose (described below).

Affected products

Product DIN Lot number Expiry date
JAMP Guanfacine XR 1 mg tablets 02523558 GFO2012 2024-SE

Issue

JAMP Pharma Corporation is recalling one lot of JAMP Guanfacine extended release (XR) 1 mg tablets because some bottles may contain JAMP Guanfacine XR 4 mg tablets in addition to the correct strength of 1 mg tablets. Patients taking a 4 mg tablet instead of a prescribed 1 mg tablet will unexpectedly receive a higher dose than intended, which may result in overdose and could pose serious health risks.

JAMP Guanfacine XR is a prescription drug used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents 6 to 17 years of age.

The 1 mg tablet is white and round with the letters 'GNF' stamped on one side and '1MG' stamped on the other.

The 4 mg tablet is green and oval with the letters 'GNF' stamped on one side and '4MG' stamped on the other.

Signs and symptoms of guanfacine overdose may include hypertension (high blood pressure), hypotension (low blood pressure), bradycardia (slow heartbeat) or abnormal heart rhythms, lethargy (drowsiness/feeling tired), respiratory depression (slowed breathing), or coma (loss of consciousness). It may take up to 24 hours for signs and symptoms of overdose to appear after taking too much of the product. Patients with suspected overdose should consult their health care professional immediately, as they may require monitoring in hospital.

Health Canada is monitoring the company's recall, and its implementation of any necessary corrective and preventative actions to stop this issue from reoccurring. The Department will inform the public if any new health risks are identified.

What you should do

  • Check your or your child's pill bottle of JAMP Guanfacine XR 1 mg tablets to ensure it contains only 1 mg white, round tablets. If it contains any JAMP Guanfacine XR 4 mg green, oval tablets, or if you are unsure, return it to your pharmacy. Your pharmacist will check it and provide you with a replacement if needed.
  • Contact a health care professional immediately if you or your child are experiencing signs and symptoms of overdose.
  • Contact JAMP Pharma Corporation by calling toll-free at 1-866-399-9091, extension 501, or by email at custjamp@jamppharma.com, if you have questions about this recall.
  • Report any health product-related side effects or complaints to Health Canada.

Additional information for health professionals:

  • Health care professionals, such as pharmacists, should check bottles of Guanfacine XR 1 mg tablets before dispensing and report any unusual bottles or other issue to the company and to Health Canada.

Additional information

Details
Original published date:
Alert / recall type
Public advisory
Category
Health products
Companies
Published by
Health Canada
Audience
Identification number
RA-74741
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