Public advisory - JAMP Digoxin 0.0625 mg and 0.125 mg tablets recalled due to possible incorrect dose, which may pose health risks

OTTAWA, ON, Aug. 2, 2024 /CNW/ -

Summary

• Product: JAMP Digoxin 0.0625 and 0.125 mg tablets
• Issue: Health products – Product safety
• What to do: If you are taking this medication, speak with your pharmacist as soon as possible. Your pharmacist will check if your product is affected and provide a replacement if needed. Contact a health care professional immediately if you or someone you are caring for experiences serious side effects, such as nausea, vomiting, abnormal vision, confusion, dizziness, difficulty breathing or heart-related effects (which can be life threatening), or difficulty breathing. Continue to take your JAMP Digoxin 0.0625 or 0.125 mg tablets until you speak with your pharmacist, as digoxin is an important drug when you have a heart condition.

Affected products

Product	DIN	Lot	Expiry
JAMP Digoxin 0.0625 mg tablets	02498502	EG24DGX001	03-2026
JAMP Digoxin 0.125 mg tablets	02498510	EG23DGY001 EG23DGY002	07-2025 07-2025

Issue
JAMP Pharma Corporation is recalling JAMP Digoxin 0.0625 and 0.125 mg tablets as some bottles may contain tablets that weigh more or less than they should, while looking like normal-sized tablets. Patients taking an overweight or underweight tablet could unexpectedly receive a higher or lower dose than intended. Digoxin is a drug where small differences in dose or blood concentration can lead to very serious side effects; therefore, it is essential that patients taking an affected JAMP product return it to the pharmacy as soon as possible for replacement.

JAMP Digoxin is a prescription drug used in children and adults to treat mild to moderate congestive heart failure. It can also be used to treat a fast or irregular heartbeat (e.g., atrial fibrillation). 

Signs and symptoms of a digoxin overdose may include nausea, vomiting, decreased appetite, diarrhea, confusion, seizures, hallucinations, vision effects (seeing light "halos" around objects, or green or yellow vision), fatigue, irregular heartbeats, and abnormally fast or slow heartbeat. In cases of severe overdose, heart-related effects could be life threatening. Children, people over the age of 65, and people who have an electrolyte or thyroid disorder may be at a higher risk of adverse effects. 

Taking a lower dose of digoxin could reduce its effectiveness and lead to a worsening of the patient's condition, which may include palpitations, dizziness, fatigue, chest pain, difficulty breathing and reduced exercise tolerance.

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

 What you should do

• If you are taking this medication, speak with your pharmacist as soon as possible. Your pharmacist will check if your product is affected and provide a replacement if needed. It may not be possible to know if you are getting the correct dose of digoxin by looking at the tablets. Overweight or underweight tablets may look like normal-sized tablets.
• Continue taking your JAMP Digoxin 0.0625 or 0.125 mg tablets until you speak with your pharmacist, as digoxin is an important drug when you have a heart condition.
• Contact a health care professional immediately if you or someone you are caring for experience serious side effects related to an overdose of digoxin or reduced efficacy of therapy.
• Contact JAMP Pharma Corporation by calling toll-free at 1-866-399-9091, extension 501, or by email at [email protected], if you have questions about this recall.
• Report any health product-related side effects or complaints to Health Canada.

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SOURCE Health Canada (HC)

Media Enquiries: Health Canada, [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709, [email protected]