Public advisory - All lots of JAMP-Mycophenolate 250 mg capsules recalled due to possible incorrect dose, which may pose health risks

OTTAWA, ON, Aug. 16, 2024 /CNW/ -

Summary

• Product: JAMP-Mycophenolate 250 mg capsules
• 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 by the recall and provide a replacement if needed. Continue to take your JAMP-Mycophenolate 250 mg capsules until you speak with your pharmacist, as mycophenolate is an important drug in preventing organ rejection in kidney, heart or liver transplant patients. Contact a health care professional immediately if you or someone you are caring for experiences serious side effects.

Affected products

Product	DIN	Lot	Expiry
JAMP-Mycophenolate 250 mg capsules	02386399	EG22MPM001 EG22PMP002 EG22MPM003 EG23MPM001 EG23MPM002 EG23MPM003	2025-08 2025-08 2025-08 2026-08 2026-08 2026-08

Issue

JAMP Pharma Corporation is recalling all lots of JAMP-Mycophenolate 250 mg capsules as some capsules may weigh less or more than they should. Patients taking an overweight or underweight capsule could unexpectedly receive a higher or lower dose than intended. Mycophenolate is a drug where differences in dose can lead to very serious side effects; therefore, it is essential that patients taking an affected product return it to the pharmacy as soon as possible for replacement.

JAMP-Mycophenolate is a prescription drug used by adults and children aged two and older after an organ transplant to help prevent organ rejection. It works by reducing or suppressing the body's immune response.

Taking a lower dose of mycophenolate could reduce its effectiveness and lead to organ rejection, which is serious. This risk is especially high in the first weeks after transplantation. General signs and symptoms of organ rejection may include pain at the site of the transplant, feeling unwell, feeling tired or having no energy, flu-like symptoms, fever, sudden weight changes, swelling, change in heart rate or urinating less often.

Taking a higher dose than intended can increase the risk of side effects, including new or worsening nausea, vomiting, and/or diarrhea. In some cases, it may lead to over-suppression of the immune system and increased risk of infections. Infections in immunosuppressed patients can be fatal.

Health Canada is monitoring the company's recall and investigation, including 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 by the recall and provide a replacement if needed. Given the capsule format, it is not possible to know whether your capsule is overweight or underweight by looking at it.
• Continue taking your medication until you speak with your pharmacist, as mycophenolate is an important drug in preventing organ rejection in kidney, heart or liver transplant patients.
• 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.

 Également disponible en français

SOURCE Health Canada (HC)

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