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

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    |    Strength  |    Size  |   DIN  |
|                 |   Ingredients  |              |          |        |
|_________________|________________|______________|__________|________|
|Jack & Jill Cough|    Guafenesin  |5 mL contains |   100mL  |00622036|
|Syrup            |    Pyrilamine  |    50 mg     |          |        |
|                 |     Maleate    |    10 mg     |          |        |
|_________________|________________|______________|__________|________|
|Jack & Jill      |Dextromethorphan|5 mL contains |   100mL  |00823023|
|Children's       |  Hydrobromide  |    7.5 mg    |          |        |
|Formula Cough    |Chlorpheniramine|     2mg      |          |        |
|Liquid           |    Maleate     |              |          |        |
|_________________|________________|______________|__________|________|
|Jack & Jill Cough|Dextromethorphan|              |   100mL  |02242588|
|& Cold           |  Hydrobromide  |5 mL contains |          |        |
|                 |Pseudoephedrine |    7.5 mg    |          |        |
|                 | Hydrochloride  |    15 mg     |          |        |
|                 |Chlorpheniramine|     1 mg     |          |        |
|                 |    Maleate     |              |          |        |
|_________________|________________|______________|__________|________|
|Jack & Jill      |Diphenhydramine |5 mL contains |   100mL  |02241167|
|Bedtime          |  Hydrochoride  |   6.25 mg    |          |        |
|_________________|________________|______________|__________|________|
|Jack & Jill      |                |10 mL contains|   100mL  |02350084|
|Expectorant      |    Guafenesin  |    100 mg    |          |        |
|_________________|________________|______________|__________|________|
|Triaminic Cough  |Dextromethorphan|              |   100mL  |02243739|
|and Cold         |  Hydrobromide  |5 mL contains |          |        |
|                 |Pseudoephedrine |     5 mg     |          |        |
|                 | Hydrochloride  |    15 mg     |          |        |
|                 |Chlorpheniramine|     1 mg     |          |        |
|                 |    Maleate     |              |          |        |
|_________________|________________|______________|__________|________|
|Triaminic Cold & |Dextromethorphan|              |   100 mL |00896179|
|Nightime Cough   |  Hydrobromide  |5 mL contains |          |        |
|                 |Pseudoephedrine |    7.5 mg    |          |        |
|                 | Hydrochloride  |     15mg     |          |        |
|                 |Chlorpheniramine|     1 mg     |          |        |
|                 |    Maleate     |              |          |        |
|_________________|________________|______________|__________|________|
|Triaminic Cough, | Acetaminophen  |              |   100 mL |02239666|
|Cold & Fever     |Dextromethorphan|5 mL contains |          |        |
|                 |  Hydrobromide  |    160 mg    |          |        |
|                 |Pseudoephedrine |    7.5 mg    |          |        |
|                 | Hydrochloride  |    15 mg     |          |        |
|                 |Chlorpheniramine|     1 mg     |          |        |
|                 |    Maleate     |              |          |        |
|_________________|________________|______________|__________|________|
|Triaminic Cough &| Acetaminophen  |5 mL contains |   100 mL |02130564|
|Sore Throat      |Dextromethorphan|    160 mg    |          |        |
|                 |  Hydrobromide  |    7.5 mg    |          |        |
|                 |Pseudoephedrine |    15 mg     |          |        |
|                 | Hydrochloride  |              |          |        |
|_________________|________________|______________|__________|________|
|Triaminic Chest &|    Guafenesin  |5 mL contains |   100 mL |02278308|
|Nasal Congestion |  Phenylephrine |    50 mg     |          |        |
|                 |  Hydrochloride |    2.5 mg    |          |        |
|_________________|________________|______________|__________|________|
|Triaminic Long   |Dextromethorphan|5 mL contains |   100 mL |02277972|
|Acting Cough     |  Hydrobromide  |    7.5 mg    |          |        |
|_________________|________________|______________|__________|________|
|Neo Citran Extra | Acetaminophen  |30 mL contains|   245 mL |02275961|
|Strength Nightime| Phenylephrine  |    650 mg    |          |        |
|Total Cold and   |  Hydochoride   |    10 mg     |          |        |
|Flu              |Diphenhydramine |    25 mg     |          |        |
|                 | Hydrochloride  |              |          |        |
|_________________|________________|______________|__________|________|
|Neo Citran Extra | Acetaminophen  |30 mL contains|   245 mL |02275988|
|Strength Daytime | Phenylephrine  |    650 mg    |          |        |
|Total Cold and   |  Hydochoride   |    10 mg     |          |        |
|Flu              |Dextromethorphan|    20 mg     |          |        |
|                 |  Hydrobromide  |              |          |        |
|_________________|________________|______________|__________|________|
|Neo Citran Extra |  Acetaminophen |30 mL contains|   245 mL |02304740|
|Strength Chest   |    Guafenesin  |    650 mg    |          |        |
|Congestion,  Cold|  Phenylephrine |    400 mg    |          |        |
|and Mucous Relief|  Hydrochloride |    10 mg     |          |        |
|_________________|________________|______________|__________|________|
|Buckley's        |                |5 mL contains |150 mL and|02279703|
|Complete         |  Acetaminophen |    325 mg    |  250 mL  |        |
|                 |     Menthol    |    20 mg     |          |        |
|_________________|________________|______________|__________|________|
|Buckley's        |                |5 mL contains |150 mL and|02357232|
|Complete with    |  Acetaminophen |    325 mg    |  250 mL  |        |
|Mucous Relief    |    Guafenesin  |    200 mg    |          |        |
|Extra Strength   |     Menthol    |    20 mg     |          |        |
|_________________|________________|______________|__________|________|
|Buckley's        | Acetaminophen  |5 mL contains |   150 mL |02356457|
|Complete PM      |Diphenhydramine |    325 mg    |          |        |
|Nightime         |  Hydrochoride  |    25 mg     |          |        |
|                 |    Menthol     |    20 mg     |          |        |
|_________________|________________|______________|__________|________| 
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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Media Inquiries: Health Canada (613) 957-2983

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

SOURCE: Health Canada

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CO: Government of Canada
ST: Ontario
NI: HEA HEA * 

-0- Jan/31/2013 19:30 GMT


 
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