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 [email protected].
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.
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SOURCE: Health Canada
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