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Ratio-Morphine Tablets Recalled in Canada due to Risk of Accidental Overdose - For Health Professionals
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(PDF Version - 29 K)Contact: Drug Compliance Verification & Investigation Unit
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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-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 CanadaDear 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 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
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.
| Morphine SR 60 mg |
Morphine SR 30 mg |
Morphine SR 15 mg |
|||
|---|---|---|---|---|---|
| Lot number | Expiry | Lot number | Expiry | Lot number | Expiry |
| 53148N | 2008.08 | 632681 | 2009.07 | 53146N | 2008.08 |
| 61063N | 2008.11 | 634315 | 2009.12 | 60322N | 2008.09 |
| 621100 | 2009.02 | 635143 | 2009.12 | 54103N | 2008.11 |
| 630632 | 2009.04 | 634635 | 2009.12 | 60982N | 2008.11 |
| 630911 | 2009.04 | 637497 | 2010.06 | 630664 | 2009.04 |
| 632440 | 2009.04 | 637799 | 2010.06 | 630665 | 2009.04 |
| 633182 | 2009.05 | 637499 | 2010.06 | 630910 | 2009.04 |
| 633396 | 2009.07 | 639430 | 2010.08 | 631837 | 2009.07 |
| 636966 | 2009.12 | 639431 | 2010.06 | 632442 | 2009.07 |
| 637230 | 2009.12 | 640266 | 2010.08 | 632976 | 2009.07 |
| 637795 | 2010.08 | 54104N | 2008.11 | 633397 | 2009.07 |
| 637796 | 2010.06 | 54105N | 2008.11 | 634313 | 2009.12 |
| 639352 | 2009.12 | 622850 | 2009.04 | 634314 | 2009.12 |
| 640018 | 2010.11 | 630078 | 2009.04 | 635142 | 2009.12 |
| 630318 | 2009.04 | 637797 | 2010.07 | ||
| 631704 | 2009.07 | 637798 | 2010.07 | ||
| 631986 | 2009.07 | 639426 | 2010.06 | ||
| 53147N | 2008.08 | 639427 | 2010.08 | ||
| 632546 | 2009.07 | 639428 | 2010.09 | ||
| 634316 | 2009.12 | 639429 | 2010.06 | ||
