Archived – Ratio-Morphine Tablets Recalled in Canada due to Risk of Accidental Overdose

Starting date:

July 9, 2008

Posting date:

July 9, 2008

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product Safety, Dosage, Labelling and Packaging

Audience:

General Public, Healthcare Professionals

Identification number:

RA-110002214

• Media enquiries
• Public enquiries

Health Canada is warning consumers not to use the prescription drug ratio-Morphine SR in 15 milligram (mg), 30 mg, and 60 mg formats. Some tablets may contain more morphine than the label indicates, exposing patients to the potential risk of accidental overdose. Oversized tablets that are noticeably thicker than the regular tablets, and which may contain more morphine than the strength indicated, have been found on the Canadian market. Ratio-Morphine SR tablets are taken orally for the relief of severe pain.

Symptoms of an overdose include abnormal breathing, dizziness, confusion or extreme drowsiness, cold or clammy skin, and abnormally low blood pressure and heart rate. A severe overdose may result in coma, cardiac arrest and death.

The Canadian distributor, ratiopharm, has initiated a recall of the affected lots after two separate complaints were received by the U.S. manufacturer, KV Pharmaceutical.

Health Canada advises consumers currently using ratio-Morphine SR at the 15 mg, 30 mg or 60 mg strength not to take these products and to contact their treating physician immediately to obtain a suitable alternative product for their medical condition. Consumers should return the product to their pharmacist for safe disposal.

Consumers who have used this product and are concerned about their health should also contact their health care practitioner for advice.

A separate communication will be sent by Ratiopharm to doctors and pharmacists notifying them of the recall and the affected lots.

As of June 30, 2008, no adverse reactions from the use of oversized ratio-Morphine SR tablets had been reported to Health Canada.

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at 613-957-2991, or toll free at
1-866-225-0709.

To report a suspected adverse reaction to these health products, please contact the Canada Vigilance Program of Health Canada by one of the following methods:

Telephone: 1-866-234-2345

Facsimile: 1-866-678-6789

Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9

E-mail: CanadaVigilance@hc-sc.gc.ca

The Canada Vigilance adverse reaction reporting form, including a version that can be completed and submitted online, is located in the MedEffect™ area of the Health Canada Web site.

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709