OTTAWA, CANADA — June 27, 2007 — sanofi-aventis Canada Inc., with agreement from Health Canada, has undertaken a voluntary recall of one lot of Fluotic® (sodium fluoride) 20 mg tablets, bottle of 100: lot number 8034613 (expiry date: September 2008).
This voluntary recall is intended to address a quality issue. In in-vitro tests, the disintegration time of some tested samples in gastric fluid-like solution was faster than usual.
Although the product is not likely to cause any adverse health consequences to the patient, there is potential risk that an early disintegration of sodium fluoride in the gastric environment may increase the risk of gastric toxicity such as gastric irritation, risk of bleeding or gastric ulcer.
While the overall risk to the patient is considered to be low, sanofi-aventis Canada Inc. has decided to recall the above lot of Fluotic® at the wholesaler, distributor and pharmacist levels as of June 1, 2007. As a result, there is currently a shortage of Fluotic® at these levels.
As well, following an annual review of our product line and due to the very limited use of the product, sanofi-aventis Canada Inc. also took the decision to discontinue, in June 2007, the marketing of Fluotic® (sodium fluoride), 20 mg tablets, which is approved for the treatment of otospongiosis.
Sanofi-aventis remains committed to the health and well being of patients. This voluntary recall is conducted with the knowledge of the Health Products and Food Branch Inspectorate of Health Canada.
Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. As always, any case of serious or unexpected adverse reactions in patients using Fluotic® should be reported to sanofi-aventis Canada Inc. or Health Canada at the following addresses:
sanofi-aventis Canada Inc.
2150 St. Elzear Blvd. West
Laval, Quebec
H7L 4A8
Toll-free telephone: 1-800-265-7927
Internet: www.sanofi-aventis.ca
Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866-234-2345
Fax: 866-678-6789
cadrmp@hc-sc.gc.ca
The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.
For other inquiries related to this communication, Health Canada should be contacted at:Marketed Health Products Directorate (MHPD)
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Tel: 613-941-3967
Fax: 613-952-9805
SOURCE: Health Canada
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