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

Starting date:

January 31, 2013

Posting date:

January 31, 2013

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Improper Safety Mechanisms

Audience:

General Public

Identification number:

RA-17193

• Report health or safety concerns
• Media enquiries
• Public enquiries
• What Health Canada is doing

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 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, 8 a.m. 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	100 mL	00622036
Jack & Jill Children's Formula Cough Liquid	Dextromethorphan Hydrobromide Chlorpheniramine Maleate	5 mL contains 7.5 mg 2mg	100 mL	00823023
Jack & Jill Cough & Cold	Dextromethorphan Hydrobromide Pseudoephedrine Hydrochloride Chlorpheniramine Maleate	5 mL contains 7.5 mg 15 mg 1 mg	100 mL	02242588
Jack & Jill Bedtime	Diphenhydramine Hydrochoride	5 mL contains 6.25 mg	100 mL	02241167
Jack & Jill Expectorant	Guafenesin	10 mL contains 100 mg	100 mL	02350084
Triaminic Cough and Cold	Dextromethorphan Hydrobromide Pseudoephedrine Hydrochloride Chlorpheniramine Maleate	5 mL contains 5 mg 15 mg 1 mg	100 mL	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

 

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