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
custjamp@jamppharma.com, 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)