2014

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

OTTAWA, Jan. 31, 2013 /CNW/ - 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.

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.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

Également disponible en français

SOURCE Health Canada



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