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Cough & Cold Products Recalled Due to Defective Caps: May Cause Serious Harm to Children

Fri, 02/01/2013 - 9:31am

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Health Canada is advising Canadians that Novartis Consumer Health Canada Inc. is conducting a voluntary recall of 17 products (see chart below) as the child resistant mechanism of the bottle cap can fail.

As a result, children may be able to open the bottle and ingest the product. The ingredients of the affected products may be harmful to children and as such, ingestion of these products may cause serious adverse health consequences, including death.

Health Canada has not received any adverse reactions regarding the defective cap issue. However, as a precautionary measure, Novartis Consumer Health Canada Inc. is voluntarily recalling these 17 products to help ensure all affected products are removed from the Canadian market.

Novartis Consumer Health Canada Inc. is requesting that retailers immediately stop sale of these products and return them to the company. The company has confirmed the products were distributed across Canada.

Health Canada is monitoring the recall by Novartis Consumer Health Canada Inc. Should new information be identified, Health Canada will provide an update to Canadians.

Health Canada reminds Canadians who have concerns about these products to consult with their health care practitioner. Consumers wishing more information on this recall can contact Novartis Consumer Health Canada Inc. at 1-866-513-6742 (Monday to Saturday, 8am to midnight EST) for further instruction. Media wishing more information on this recall may contact Milicent Brooks, Novartis Consumer Health, Inc., 1-973-503-7483 or via email at milicent.brooks@novartis.com.

The following information will help consumers identify affected product and can be found on the label on the product, as well as on any outer packaging.

Recalled Products

Product Name

Active Ingredients

Strength

Size

DIN

Jack & Jill Cough Syrup

Guafenesin
Pyrilamine Maleate

5 mL contains
50 mg
10 mg

100mL

00622036

Jack & Jill Children's Formula Cough Liquid

Dextromethorphan Hydrobromide
Chlorpheniramine Maleate

5 mL contains
7.5 mg
2mg

100mL

00823023

Jack & Jill Cough & Cold

Dextromethorphan Hydrobromide
Pseudoephedrine Hydrochloride
Chlorpheniramine Maleate

5 mL contains
7.5 mg
15 mg
1 mg

100mL

02242588

Jack & Jill Bedtime

Diphenhydramine Hydrochoride

5 mL contains
6.25 mg

100mL

02241167

Jack & Jill Expectorant

Guafenesin

10 mL contains
100 mg

100mL

02350084

Triaminic Cough and Cold

Dextromethorphan Hydrobromide
Pseudoephedrine Hydrochloride
Chlorpheniramine Maleate

5 mL contains
5 mg
15 mg
1 mg

100mL

02243739

Triaminic Cold & Nightime Cough

Dextromethorphan Hydrobromide
Pseudoephedrine Hydrochloride
Chlorpheniramine Maleate

5 mL contains
7.5 mg
15mg
1 mg

100 mL

00896179

Triaminic Cough, Cold & Fever

Acetaminophen
Dextromethorphan Hydrobromide
Pseudoephedrine Hydrochloride
Chlorpheniramine Maleate

5 mL contains
160 mg
7.5 mg
15 mg
1 mg

100 mL

02239666

Triaminic Cough & Sore Throat

Acetaminophen
Dextromethorphan Hydrobromide
Pseudoephedrine Hydrochloride

5 mL contains
160 mg
7.5 mg
15 mg

100 mL

02130564

Triaminic Chest & Nasal Congestion

Guafenesin
Phenylephrine Hydrochloride

5 mL contains
50 mg
2.5 mg

100 mL

02278308

Triaminic Long Acting Cough

Dextromethorphan Hydrobromide

5 mL contains
7.5 mg

100 mL

02277972

Neo Citran Extra Strength Nightime Total Cold and Flu

Acetaminophen
Phenylephrine Hydochoride
Diphenhydramine Hydrochloride

30 mL contains
650 mg
10 mg
25 mg

245 mL

02275961

Neo Citran Extra Strength Daytime Total Cold and Flu

Acetaminophen
Phenylephrine Hydochoride
Dextromethorphan Hydrobromide

30 mL contains
650 mg
10 mg
20 mg

245 mL

02275988

Neo Citran Extra Strength Chest Congestion,  Cold and Mucous Relief

Acetaminophen
Guafenesin
Phenylephrine Hydrochloride

30 mL contains
650 mg
400 mg
10 mg

245 mL

02304740

Buckley's Complete

Acetaminophen
Menthol

5 mL contains
325 mg
20 mg

150 mL and
250 mL

02279703

Buckley's Complete with Mucous Relief Extra Strength

Acetaminophen
Guafenesin
Menthol

5 mL contains
325 mg
200 mg
20 mg

150 mL and
250 mL

02357232

Buckley's Complete PM Nightime

Acetaminophen
Diphenhydramine Hydrochoride
Menthol

5 mL contains
325 mg
25 mg
20 mg

150 mL

02356457

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.

-30-


Media Enquiries:
Health Canada
(613) 957-2983

Public Enquiries:
(613) 957-2991
1-866 225-0709

 

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