Personnelle cold and flu products recalled due to a labeling error

Starting date:
August 23, 2013
Posting date:
August 23, 2013
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Labelling and Packaging
Audience:
General Public
Identification number:
RA-35283

Issue

Vita Health Products Inc., in consultation with Health Canada, is voluntarily recalling certain lots of “Personnelle Cold and Flu-in-One Extra Strength” and “Personnelle Flu Relief” due to a labeling error.

Important warnings and overdose information are printed on the inside of the box. Since there are no directions to check the inside of the box, consumers may miss this important consumer safety information.

Products affected

  • Personnelle Cold and Flu-in-One Extra Strength - Lots: 1K107B2NVR; 2D070B2QH1; 2D214B2S0F; 2G121B2U8N; 2G121B2UA0; 2G198B2UA0; 2J094B31AX
  • Personnelle Flu Relief - Lot: 00067288

What you should do

  • Read the warnings on the inside of the outer product packaging (also available below).
  • Consult your healthcare practitioner (as outlined in the warning information provided below) if you have used any of these products and have concerns about your health.
  • Consumers who have any questions about these products may call Vita Health Products at 1-800-665-8820, Monday-Friday 9:00 am – 5:30 pm EDT for further information.
  • Report any adverse reactions to Health Canada.

Who is affected

Consumers who have purchased these products.

Background

Personnelle Cold and Flu-in-One Extra Strength - Warnings on the inside of the outer product packaging

WARNING. 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 or 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.

Personnelle Flu Relief - Warnings on the inside of the outer product packaging:

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 recur 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 use 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 centre immediately, even if you do not notice any signs or symptoms. Within the first 24 hours, you may experience increased sweating, nausea, vomiting, stomach pain and loss of appetite.

Report health or safety concerns

  • Call toll-free at 1-866-234-2345
  • Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709

What Health Canada is doing

Health Canada is monitoring Vita Health’s recall and ongoing review of packaging and labeling practices and will inform Canadians if new information comes to light.

Vita Health Products Inc. has informed Health Canada that as of August 21, 2013, there had been no adverse reactions reported concerning these products. As well, Health Canada had not received any adverse reaction reports related to this issue as of July 31, 2013.

Images

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For more information

More information is also available from Vita Health Products Inc. by calling 1-800-665-8820, Monday-Friday 9:00 a.m. – 5:30 p.m. EDT or their website.