Vita Health recalls numerous Over-the-counter products because of labelling errors

Starting date:

September 6, 2013

Posting date:

October 17, 2013

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Labelling and Packaging

Audience:

General Public

Identification number:

RA-35525

• Issue
• Report health or safety concerns
• Media enquiries
• Public enquiries

Issue

Health Canada wishes to inform Canadians that Vita Health Products Inc. has voluntarily recalled a variety of health products from the Canadian market because of labelling issues. The recalled products pose a risk to health because the labels contain errors such as suggesting packages are child resistant when they are not, or are missing warning statements for consumers with allergies or existing medical conditions.

The products include "over-the-counter" and a natural health product such as anti-inflammatory, cold and flu, allergy and sinus, and acetaminophen medications.

Vita Health is reviewing its product labels and putting actions in place to address the labelling issues. Health Canada has not received any information suggesting the quality of the products on the list below is affected.

If you have used or purchased a Vita Health product and are concerned about its impact on your health, please consult your healthcare practitioner. Consumers are also encouraged to return the product to the place of purchase or call Vita Health at 1-800-665-8820, Monday-Friday 9:00 a.m. - 5:30 p.m. EDT for further instruction.

Health Canada is monitoring the recalls by Vita Health and will continue to provide updates to Canadians as warranted. Canadians can monitor the table below for additions to the list of recalled products. The table includes a complete list of products recalled by Vita Health to date.

List of products recalled by Vita Health to date

Product	Labelling Error	At Risk Population	Date of Recall
iVita Children's Chewable Multivitamins	Label declares no gluten/lactose/preservatives/yeast, however lactose and sodium benzoate (a preservative) are present and  listed in the non medicinal ingredients.	Children with lactose and sodium benzoate intolerance.	October 17,   2013
Nature’s Bounty Extra Strength Melatonin	Missing warning statement in French	General Public	October 2, 2013
Rexall Melatonin	Missing warning statement in French	General Public	October 2, 2013
Remedy's Rx Cold + Sinus 20 tablets (Lot numbers: 2A218B2ML8 and 2A219B2ML8)	Packaging suggests product is child resistant	Children	October 1, 2013
Pharmasave Extra Strength Ibuprofen Liquid Capsules, 400 mg 12 capsules (Lot numbers: 2C0692RK5 2F0942S0P, 2I2242W9G)	Packaging suggests product is child resistant	Children	October 1, 2013
Equate Extra Strength Allergy Sinus Medication	Missing warning statement in French	General Public	September 26, 2013
Encounter Cold & Flu-In-One Extra Strength	Missing warning statement in French	General Public	September 26, 2013
Pharmasave Cold & Flu-In-One Extra Strength	Missing warning statement in French	General Public	September 26, 2013
Life Brand Extra Strength Muscle and Back Pain Relief	Warning statement is missing 'kidney disease, chronic alcoholism and intake of central nervous system (CNS) depressants'	Those with kidney disease, chronic alcoholism or those who take CNS depressants	September 18, 2013
Encounter Junior Strength Acetaminophen Tablets 160 mg (Lot Number: 1J0572FVM)	Missing warning statement	Children	September 17, 2013
Encounter Junior Strength Acetaminophen Tablets 160 mg (Lot Number: 3B215317J)	Incorrect dosing directions on inner label	Children 6 years of age and under	September 17, 2013
Personnelle Cold and Flu-in-One Extra Strength Convenience Pack	Missing reference to important information	General population	September 12, 2013
Personnelle Ultra Headache Relief	Missing warning statement in French	General population	September 9, 2013
Personnelle Acid Control	Missing reference to important information	General population	September 5, 2013
Personnelle Cold and Flu-in-One Extra Strength	Missing reference to important information	General population	August 20, 2013
Personnelle Flu Relief	Missing reference to important information	General population	August 20, 2013
Exact Extra Strength Allergy Sinus Medication	Missing warning statement	People with chronic lung disease	August 16, 2013
Rexall Extra Strength Allergy Sinus Medication	Missing warning statement	People with chronic lung disease	August 16, 2013
Tanta Extra Strength Allergy Sinus Medication	Missing warning statement	People with chronic lung disease	August 16, 2013
Life Extra Strength Allergy Sinus	Missing warning statement	People with chronic lung disease	August 13, 2013
Safeway and Compliments Ibuprofen Liquid Capsules	Packaging suggests product is child resistant	Children	July 29, 2013
Compliments Iron Ferrous Gluconate	At least one bottle of Iron Ferrous Sulphate was labelled as Iron Ferrous Gluconate	People with an allergy to sulphate	July 25, 2013
Pharmasave Extra Strength Allergy Sinus Medication	Missing caution statement in French	General Public	July 22, 2013
Exact Cold Medication	Missing caution statement in French	General Public	July 22, 2013
London Drugs Acetaminophen 300 mg with 15 mg caffeine and 8 mg codeine	Missing caution statement	General Public	July 22, 2013
Extra Strength Cold and Flu-In-One	Missing caution statement	Children	July 22, 2013
Selection Extra Strength Flu Relief Daytime	Missing caution statement in French	General Public	July 22, 2013
Option+ Extra Strength Flu Relief Daytime	Missing caution statement in French	General Public	July 22, 2013
Rexall Extra Strength Flu Relief Daytime	Missing caution statement in French	General Public	July 22, 2013
Western Family Extra Strength Cold and Flu-In-One	Missing warning statement	Children	July 22, 2013
Safeway Extra Strength Ibuprofen	Packaging suggests product is child resistant	Children	June 5, 2013
Compliments Extra Strength Acetaminophen Gelcaps	Packaging suggests  product is child resistant	Children	April 16, 2012
Biomedic Ultra Headache Relief	English panel missing the ingredient caffeine	General Public	November 30, 2012
Compliments Muscle and Back Pain Relief Regular Strength	French dosing directions	Children	December 29, 2011

 

Report health or safety concerns

How to report side effects to health products to Health Canada:

• 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