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Voluntary Type 1 Recall of ratio-Valproic (valproic acid) 500-mg Enteric-Coated Capsules in Canada - For Health Professionals
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(PDF Version - 112 K)Contact DCVIU UVCEM
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.
May 11, 2007
Subject: URGENT - Voluntary Type 1 Recall of ratio-Valproic (valproic acid) 500-mg Enteric-Coated Capsules in Canada
Dear Health Care Professional,
ratiopharm inc. is advising health care professionals of the immediate voluntary recall of all lots of ratio-Valproic (valproic acid) 500-mg enteric-coated capsules (DIN 02140055) due to stability test failures: routine stability testing has indicated that the product's shelf life is not as long as marked on the packaging. As a result, a lesser amount of active ingredient may be released. This may result in inadequate seizure control, potentially putting patients at risk for a greater number of seizures.
ratio-Valproic (valproic acid) is indicated as sole or adjunctive therapy in the treatment of simple or complex absence seizures, including petit mal, and is useful in primary generalized seizures with tonic-clonic manifestations. It may also be used adjunctively in patients with multiple seizure types which include either absence or tonic-clonic seizures.
Prescribers:
- Immediately identify and determine alternative treatment options for patients currently taking ratio-Valproic (valproic acid) 500-mg enteric-coated capsules;
- Do not initiate treatment of new patients with ratio-Valproic (valproic acid) 500-mg enteric-coated capsules.
Pharmacists:
- Do not dispense further prescriptions for ratio-Valproic (valproic acid) 500-mg enteric-coated capsules;
- Immediately contact the patients' physician to identify and determine alternative treatment options for all patients currently taking ratio-Valproic (valproic acid) 500-mg enteric-coated capsules;
- Do not return any ratio-Valproic 500 mg enteric-coated capsules until contacted by your wholesaler or distributor.
Patients currently taking ratio-Valproic (valproic acid) 500-mg enteric-coated capsules should immediately contact their doctor or pharmacist to identify and determine other treatment options.
No other ratio-Valproic formulation or ratiopharm product is affected by this action.
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-Valproic (valproic acid) 500-mg enteric-coated capsules should be reported to ratiopharm or Health Canada at the following addresses:
17800, Lapointe
Mirabel QC J7J 1P3
Tel : 1-800-667-6030
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: 613-57-0335
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, please contact Health Canada at:
Health Products and Food Branch Inspectorate - Drug Compliance Verification & Investigation Unit (DCVIU)
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 613-941-3967
Fax: 613-952-9805
ratiopharm reiterates its commitment to the health and safety of patients and the delivery of quality products.
Should you have any questions or require additional information regarding the recall of ratio-Valproic (valproic acid) 500-mg enteric-coated capsules, please contact ratiopharm at 1-800-667-6030
Sincerely,
original signed by
Martha Kahne-Mercure
Vice-President Quality
ratiopharm
