Personnelle Flu Relief

Starting date:

August 20, 2013

Posting date:

September 9, 2013

Type of communication:

Drug Recall

Subcategory:

Drugs

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Product Safety

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-35327

• Reason
• Depth of distribution
• Affected products

Recalled Products

Personnelle Flu Relief

Reason

The blister boxes with warnings printed on the interior are missing the following mandatory statement “see inner printing for additional important information” on the outer panels.  The following warnings were included on the inner printing of the box:

ADDITIONAL INFORMATION FOR THE CONSUMER.  WARNING. Talk to a doctor if the fever persist for more than 3 days or symptoms last more than 5 days, if cough worsens, tends to reoccur or is accompanied by high fever (>38ºC) or the production of yellow/green phlegm, or if you develop nervousness, dizziness, sleeplessness, or allergic reactions such as wheezing, rash, or itching.  Consult a doctor or pharmacist prior to use if you any other medications, including natural health products, prescription drugs, salicylates or other pain and fever relief medications (nonsteroidal anti-inflammatory drugs NSAIDS)), if you have chronic alcoholism, serious kidney or liver disease, heart or thyroid disease, asthma, glaucoma, or difficult in urination due to an enlargement of the prostate gland or if you are pregnant or nursing.  Nighttime caplets may cause drowsiness or excitability.  Avoid alcohol, driving or other activities requiring alertness.  Not to be used by elderly patients who experience confusion at nighttime.  These drugs may produce excitation rather than sedation in the elderly.  Therefore they should be avoided in this age group.

IN CASE OF OVERDOSE: Call a doctor or poison control center immediately, even if you do not notice any signs or symptoms.  Within the first 24 hours, you may experience increased seating, nausea, vomiting, stomach pain and loss of appetite.

Depth of distribution

Distributed to the retail level.  Nationally in Canada only.

Affected products