OTTAWA,
ON, Sept. 27, 2024 /CNW/ -
Summary
- Product: M-Eslon (morphine sulfate) bottles labelled to
contain 30 mg extended-release capsules may contain 60 mg
extended-release capsules
- Issue: Health products – Product safety
- What to do: Check your M-Eslon (morphine sulfate)
medication bottle or package. If your prescription is for 30 mg
capsules and the bottle contains 60 mg capsules, or if you are
unsure, do not take these capsules and return them to
your pharmacy. If you or someone you are caring for is experiencing
an overdose (symptoms are described below), call 911
immediately and seek immediate medical attention
Images
Affected products
Product
|
DIN
|
Lot
number
|
Expiry
date
|
M-Eslon (morphine
sulfate) extended release capsules – bottles from the manufacturer
are labelled as 30 mg
|
02019949
|
43885
|
04/2026
|
Issue
Ethypharm Inc. is recalling one lot of M-Eslon (morphine
sulfate) extended release (ER) capsules because some bottles
labelled as M-Eslon 30 mg ER may contain 60 mg capsules. This issue
could lead to patients receiving a 60 mg dose instead of their
prescribed 30 mg dose, which could result in an overdose and pose
serious health risks.
M-Eslon is a prescription opioid drug used by adults for
long-term pain management when pain is severe enough to require
daily, around-the-clock painkillers and other treatment options are
not able to treat the pain.
The 60 mg capsule has "60" and "M-ESLON" printed on it. The
capsule has an opaque orange cap and a clear bottom.
The 30 mg capsule has "30" and "M-ESLON" printed on it. The
capsule has an opaque pink cap and a clear bottom.
Taking too much morphine or suddenly increasing the dose could
potentially lead to an overdose, which can be life-threatening.
Symptoms of morphine overdose may include: confusion, dizziness,
drowsiness, difficulties waking up, small (pinpoint) pupils, slow
heartbeat, slow and difficult breathing, cold and clammy skin,
fainting, seizure, coma and death.
Health Canada is monitoring the
company's recall and investigation, including its implementation of
corrective and preventive 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 M-Eslon (morphine sulfate) medication bottle or
package. If your prescription is for 30 mg, the capsules should be
pink and clear. If it contains 60 mg capsules (orange and clear),
or if you are unsure, do not take these capsules and contact
your pharmacy immediately. Your pharmacist will check the capsules
and provide you with a replacement if needed. Return the affected
product to your pharmacy for proper disposal.
- Call 911 immediately and seek immediate medical
attention if you or someone you are caring for is experiencing an
overdose (e.g., slow breathing, drowsiness, or difficulties waking
up).
- If an overdose is suspected, administer naloxone nasal spray
or injection without delay. Give a repeat dose after 2 to 3
minutes if the person has not woken up or their breathing has not
improved.
- Contact your health care professional if you have taken the
wrong dose of your medication and have any health concerns.
- If you have questions about this recall contact Ethypharm Inc.
by calling 1-855-694-0151, or by emailing
customerservice@valeopharma.com.
- 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 labelled as M-Eslon (morphine sulfate) 30 mg extended
release (ER) capsules before dispensing to make sure they do not
contain M-Eslon 60 mg ER capsules. Report any unusual bottles or
other issues to the company and to Health Canada.
Également disponible en français
SOURCE Health Canada (HC)