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Health product recall

Personnelle Cold and Flu-in-One Extra Strength Convenience Pack (2013-09-12)

Starting date:
September 12, 2013
Posting date:
September 20, 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-35847

Recalled Products

Personnelle Cold and Flu-in-One Extra Strength Convenience Pack

Reason

The outer box does not reference to “see inner printing for important additional information”. The inner printing contains the following English and French sections:

CAUTION: Consult a doctor if sore throat pain persists for more than 2 days, fever lasts for more than 3 days or symptoms more than 5 days, if cough worsens, tends to recur, is accompanied by high fever (>38◦C) or the production of yellow/green phlegm, or if you develop allergic reactions such as wheezing, rash or itching. Ask 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)), 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 prostrate gland or if you are pregnant or nursing.  Use only on the advice of a physician. Not recommended for patients with asthma, shortness of breath or persistent chronic cough unless directed by a physician. Avoid alcohol. Nighttime caplets may cause drowsiness or excitability. Do not drive or engage in activities requiring mental alertness.

IN CASE OF OVERDOSE:  Call a doctor or Posion 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

Depth of distribution

Distributed to the retail level.  Nationally in Canada only.

Affected products

A) Personnelle Cold and Flu-in-One Extra Strength Daytime

DIN, NPN, DIN-HIM

DIN 02281147

Dosage form

Tablet

Strength
  • Dextromethorphan Hydrobromide, 15 mg
  • Pseudoephedrine Hydrochloride, 30 mg
  • Guaifenesin, 100 mg
  • Acetaminophen, 500 mg
Lot or serial number
  • 00062140
  • 00062850
Companies
Recalling Firm

Vita Health Products Inc.

150 Beghin Ave.

Winnipeg

R2J 3W2

Manitoba

CANADA

Marketing Authorization Holder

Vita Health Products Inc.

150 Beghin Ave.

Winnipeg

R2J 3W2

Manitoba

CANADA



B) Personnelle Cold and Flu-in-One Extra Strength Nighttime

DIN, NPN, DIN-HIM

DIN 02298171

Dosage form

Tablet

Strength
  • Pseudoephedrine Hydrocloride, 30 mg
  • Acetaminophen, 500 mg
  • Diphehydramine Hydrochloride, 25 mg
Lot or serial number
  • 00062140
  • 00062850
Companies
Recalling Firm

Vita Health Products Inc.

150 Beghin Ave.

Winnipeg

R2J 3W2

Manitoba

CANADA

Marketing Authorization Holder

Vita Health Products Inc.

150 Beghin Ave.

Winnipeg

R2J 3W2

Manitoba

CANADA