Personnelle Cold and Flu-In-One Extra Strength

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-35325

• Reason
• Depth of distribution
• Affected products

Recalled Products

Personnelle Cold and Flu-In-One Extra Strength

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 in the inner printing of the box:

Consult a doctor if sore throat pain persists for more than 2 days, if fever persists for more than 3 days or symptoms more than 5 days, if cough worsens, tends to reoccur, or is accompanied by high fever (>38 ºC) 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 use any other medications, including natural health products, prescription drugs, salicylates or other pain and fever medications (nonsteroidal anti-inflammatory drugs (NSAIDS)), if you have chronic alcoholism, serious kidney or liver disease, heart of thyroid disease, chronic lung disease, high blood pressure, diabetes, glaucoma, difficulty in urination due to an enlargement of the prostate gland or if you are pregnant or nursing.  Not recommended for patients with asthma, shortness of breath or persistent chronic cough unless directed by a physician.  Avoid alcohol.

IN CASE OF OVERDOSE: Call a doctor or poison control centre immediately, even if you do no notice any signs or symptoms.  Within the first 24 hours, you may experience increased sweating, nausea, vomiting, stomach pain and loss of appetite.

Depth of distribution

Distributed to the retail level. Nationally in Canada only.

Affected products