Four acetaminophen products for children and infants recalled due to quality concerns

Starting date:
May 23, 2013
Posting date:
May 23, 2013
Type of communication:
Advisory
Subcategory:
Drugs, Affects children, pregnant or breast feeding women
Source of recall:
Health Canada
Issue:
Quality
Audience:
General Public
Identification number:
RA-33607

Issue

Health Canada has been made aware of quality concerns with a manufacturer in China that produces acetaminophen (Paracetamol) as an ingredient for health products. Health Canada has identified four products intended for children and infants that contain acetaminophen from this manufacturer. Prestige Brands, which manufactures the final products, is voluntarily recalling all their affected products from the marketplace. This is being done as a precaution only.

Products affected
Product Name DIN Strength
Children's Little Remedies for Fevers - Grape 02385198 160 mg/5 mL
Children's Little Remedies for Fevers - Cherry 160 mg/5 mL
Infant's Little Remedies for Fevers - Berry 02385171 80 mg/mL
Infant's Little Remedies for Fevers - Grape 80 mg/mL

 

What you should do

  • If you have purchased any of the products identified below, do not use them and properly dispose of them.
  • Contact your healthcare practitioner with any questions or concerns regarding the use of these products.
  • Report any adverse reaction potentially related to these products to Health Canada.
  • Contact Health Canada’s toll-free line at 1-800-267-9675 with questions or complaints about these products.

Who is affected

As of May 23, 2013, Health Canada has not received any adverse reactions associated with these products. The population at risk includes children and infants.

Background

During a recent inspection by European Directorate for the Quality of Medicines and Healthcare (EDQM) of Changshu Huagang Pharmaceutical Co. Ltd., Yuxiang Yetang Town, Changshu Jiangsu, China, the EDQM identified concerns with the manufacturer’s good manufacturing practices (GMP) and potential microbial and/or environmental contamination due to unsanitary conditions at the manufacturing facility.

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 has requested the Canadian distributor to recall all affected products, which the company has agreed to do. Further, Health Canada will continue to monitor the effectiveness of the recall.

At this time, these are the only affected products identified by Health Canada. Should Health Canada become aware of other affected products, the Department will inform Canadians and work with the manufacturers and/or distributors to have the products removed from the marketplace.

Images

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For more information

Parents wishing more information about these products are encouraged to contact Prestige Brands at 1-800-754-8853.