Health Canada
www.hc-sc.gc.ca
Common menu bar links
Important Safety Information on ratio-Metformin 500mg lot 638812 - For Health Professionals
Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
(PDF Version - 174 K)Contact: Drug Compliance Verification & Investigation Unit
The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from ratiopharm inc.
Contact the company for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Safety Information on ratio-Metformin 500mg lot 638812
July 18, 2008
Subject: Important information regarding ratio-Metformin 500mg lot 638812Dear Health Care Professional,
ratiopharm, following discussions with Health Canada, would like to inform you that there is a possibility that bottles of ratio-Metformin 500mg lot 638812 may contain stray tablets of ratio-Lovastatin 40mg. This situation arises from a product complaint.
- Bottles of ratio-Metformin 500mg lot 638812 may contain stray tablets of ratio-Lovastatin 40mg
- ratio-Lovastatin is a lipid metabolism regulator that is contraindicated in cases of hypersensitivity to any component of this medication, active liver disease or unexplained persistent elevations of serum transaminases. ratio-Lovastatin is also contraindicated in pregnancy and lactation.
- ratio-Metformin is white and round whereas ratio-Lovastatin is mint green and octagon-shaped.
- ratiopharm is recommending that pharmacists that use automatic counting machines should manually dispense or visually inspect ratio-Metformin 500mg lot 638812.
It is important that patients continue to take their current therapies and not discontinue using their medications.
If a pharmacist or any pharmacy personnel should discover a tablet of ratio-Lovastatin 40mg, he or she should contact the Customer Service Department of ratiopharm at 1-800-337-2584.
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious or unexpected adverse reactions in patients receiving ratio-Metformin or ratio-Lovastatin should be reported to ratiopharm or Health Canada at the following addresses:
ratiopharm inc.
17800, Lapointe
Mirabel, QC
J7J 1P3
Tel.: 1-800-337-2584
Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
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
CanadaVigilance@hc-sc.gc.ca
The Adverse Reaction Reporting Form and the Adverse Reaction 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, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Tel.: 613-954-6522
Fax: 613-952-7738
The situation is currently under investigation and additional information and/or corrective measures will be communicated as necessary. Should you have any questions or require further clarification, please contact ratiopharm Customer Service at 1-800-337-2584.
Yours sincerely,
original signed by
Martha Kahne Mercure
Vice-President, Quality
