Advisory - Clavulin-400 liquid oral antibiotic: One lot recalled after glass pieces found in one bottle

OTTAWA, April 17, 2015 /CNW/ -

The issue:

In consultation with Health Canada, GlaxoSmithKline Inc. (GSK) is voluntarily recalling one lot (lot 710535) of Clavulin-400 (70mL) after receiving a complaint from a pharmacy that two glass pieces had been found in one bottle of the  product. No other lots of GSK Clavulin products are affected at this time.

Clavulin-400 is an oral antibiotic used in adults and children aged 12 weeks and older to treat various bacterial infections. Clavulin-400 comes as a powder in bottles and is mixed with purified water by a pharmacist before dispensing. The mixed product is a liquid taken by mouth and can be stored refrigerated for seven days.

Products affected:

• Clavulin-400 Oral Suspension Product (DIN 02238830), Lot 710535

Who is affected: Consumers including parents and caregivers who have purchased or used Clavulin-400 or who have provided it to their children.

What consumers should do:

• If you have product from the affected lot, return it to the pharmacy for a replacement.
• If you are unable to determine the lot of the medication that you have, contact the pharmacy from where the medication was received and confirm that it is not from the affected lot.
• Contact your healthcare professional to obtain medical advice if you have taken any of the affected product and have concerns about your health
• Report any adverse events to Health Canada.

What Health Canada is doing:

Health Canada is monitoring the recall and the company's preventative and corrective actions and will inform Canadians should new safety information become available.

Background:

GSK advised Health Canada that they received a complaint from a pharmacy that had identified two pieces of glass in one bottle of Clavulin-400 (Lot 710535). According to GSK, a total of 29,949 bottles from the affected lot (Lot 710535) have been distributed in Canada since March 10, 2015. This is the only complaint GSK has received of this nature.

Since the product is prepared and dispensed by a pharmacist, the potential for accidental ingestion of the glass particles is very remote. Risks associated with ingestion of a sharp piece of glass potentially include choking, stomach pain, vomiting, cuts, and blockage or holes in the esophagus or gastrointestinal tract.

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

PDF available at: http://stream1.newswire.ca/media/2015/04/17/20150417_C8271_PDF_EN_14432.pdf

Media Enquiries: Health Canada, [phone]; Public Enquiries: [phone], 1-866 225-0709