Warning

2005-33
April 29, 2005
For immediate release

Health Canada warns consumers not to consume a certain Lot Number of pms-Sodium Polysterene Sulfonate Powder for Suspension

OTTAWA - Health Canada is warning consumers not to consume Lot Number 409366 of pms-Sodium Polysterene Sulfonate Powder for Suspension due to an error in labelling that may result in serious complications. The mislabelled lot instructs users to take an incorrect dose -4 tablespoon up to four times a day, which is three times the actual recommended dose of 4 teaspoon up to four times per day.

This product is prescribed to reduce elevated levels of potassium in the body that can result from conditions such as chronic kidney diseases. If taken as labelled, the product may reduce potassium below normal levels. The effects of this can vary depending on how low the potassium level becomes. Symptoms of low potassium can include irritability, confusion, electrocardiogram (ECG) abnormalities, irregular heartbeat and severe muscle weakness. Severe reductions in potassium can be life threatening. Longer term use at these overdose levels may contribute to sodium retention and water retention particularly in patients with kidney problems and possibly congestive heart failure.

The product, distributed by Pharmascience Inc. of Montreal, bears the Drug Identification Number 00755338. It is sold as a powder in 454g white plastic bottles and the affected lot, distributed on April 8, 2005, has an expiry date of January 2010.

A recall of the affected lot has been voluntarily initiated by the firm to all retailers and wholesalers in Canada.

Anyone having purchased pms-Sodium Polysterene Sulfonate Powder for Suspension since April 8, 2005 is asked to verify correct dosing instructions with their pharmacist and contact their health care professional for further advice.

Health Canada has received one complaint associated with the use of this product and continues to monitor the effectiveness of the recall.

The public is encouraged to inform Health Canada if they see these products for sale, or if they have any questions about this advisory by contacting the Health Products and Food Branch Inspectorate toll free number (1-800-267-9675).

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Media Inquiries:
Health Canada
(613) 957-2983

Public Inquiries:
(613) 957-2991