Ratio-Morphine Tablets Recalled in Canada due to Risk of Accidental Overdose - For Health Professionals

Starting date:

July 8, 2008

Posting date:

July 14, 2008

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170001880

This is duplicated text of a letter from ratiopharm Inc.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on ratio-Morphine SR 15 mg, 30 mg and 60 mg tablets

July 8, 2008

Subject: Urgent - Voluntary Type 1 Recall of ratio-Morphine SR 15 mg, 30 mg and 60 mg tablets in Canada

Dear Health Care Professional,

ratiopharm Inc., in consultation with Health Canada, is advising health care professionals of the immediate voluntary recall of a number of lots (see in attachment) of ratio-Morphine SR 15 mg, 30 mg and 60 mg tablets (DIN 02244790 - 02244791 - 02244792) due to the possibility that they may contain oversized tablets. The lots are being recalled as a precaution. The voluntary recall follows a report that tablets with as much as double the appropriate thickness were identified creating the possibility of taking double the dose prescribed.

If patients ingest oversized tablets they would be exposed to the potential risk of accidental overdose. The most important signs of overdose are respiratory depression, dizziness, confusion or extreme drowsiness. Serious overdosage may result in apnea, circulatory collapse, cardiac arrest and death.

Prescribers

• Immediately identify and determine alternative treatment options for patients currently taking ratio-Morphine SR 15 mg, 30 mg and 60 mg tablets.

Pharmacists

• Immediately contact the patient's physician so that the physician can identify and determine alternative treatment options for a patient currently taking ratio-Morphine SR 15 mg, 30 mg and 60 mg tablets;
• Do not return ratio-Morphine SR 15 mg, 30 mg and 60 mg tablets until contacted by your wholesaler or distributor.

ratio-Morphine SR is indicated for the relief of severe pain that requires prolonged use of an opioid analgesic preparation.

There have been no reported health and safety incidents associated with the product involved in this action. ratiopharm is initiating this voluntary recall as a precautionary measure.

Patients currently taking ratio-Morphine SR 15 mg, 30 mg and 60 mg tablets are advised to immediately contact their health care provider to identify and determine other treatment options. ratiopharm currently has product that is not included in this recall, they are lots 641826 (60 mg), 641825 (30 mg) and 641823 (15 mg).

No other ratio-Morphine 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-Morphine SR 15 mg, 30 mg and 60 mg tablets should be reported to ratiopharm or Health Canada at the following addresses:

ratiopharm Inc.

17800, Lapointe

Mirabel QC J7J 1P3

Telephone: 1-800-667-6030

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

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

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-Morphine SR 15 mg, 30 mg and 60 mg tablets, please contact ratiopharm at 1-800-667-6030

Sincerely,

original signed by

Martha Kahne-Mercure

Vice-President Quality

ratiopharm Inc.