Public advisory - JAMP Digoxin tablets: One lot recalled due to possible oversized tablets which may pose overdose risk

OTTAWA, ON, May 31, 2024 /CNW/ - 

• Product: JAMP Digoxin 0.0625 mg tablets (lot EG23DGX001, expiry 07-2025)
• Issue: Health products ? Product safety
• What to do: Return your JAMP Digoxin 0.0625 mg tablets to your pharmacy for replacement as soon as possible. Until you can return them, continue to take your JAMP Digoxin, but do not take any tablets that look oversized compared to your normal tablets (see image, which shows an oversized tablet on the left and proper-sized tablet on the right). If you are unsure whether your product is affected, check with your pharmacy. Contact a health care professional immediately if you or someone you are caring for experiences serious side effects, such as vomiting, confusion, vision effects or heart-related effects. 

JAMP Pharma Corporation is recalling one lot of JAMP Digoxin 0.0625 mg tablets as some bottles may contain thicker, oversized tablets. Patients taking an oversized tablet will unexpectedly receive a higher dose than intended, which may pose serious health risks, including overdose. Digoxin is a drug where small differences in dose or blood concentration can lead to side effects, therefore it is very important that all patients taking the affected JAMP product return it to the pharmacy 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 heartbeat, 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.  

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.

• Return your JAMP Digoxin 0.0625 mg tablets to your pharmacy for replacement as soon as possible. Until you can return them, continue to take your JAMP Digoxin but do not take tablets that look oversized (see image, which shows an oversized tablet on the left and proper-sized tablet on the right). If you are unsure whether your product is affected, check with your pharmacy.
• Contact a health care professional immediately if you or someone you are caring for experience serious side effects. 
• 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.

• Health care professionals, such as pharmacists, should check bottles of JAMP Digoxin 0.0625 mg tablets before dispensing and report any unusual tablets to the company and to Health Canada.

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SOURCE Health Canada (HC)