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Health Canada Endorsed Important Safety Information Regarding ratio-Paroxetine – ratiopharm Inc. – For Health Professionals

Starting date:
April 14, 2005
Posting date:
April 20, 2005
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Labelling and Packaging
Audience:
Healthcare Professionals
Identification number:
RA-170001190

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

 
[Text of letter begins]

Health Canada Endorsed Important Safety Information regarding ratio-PAROXETINE

April 14, 2005

Subject: Concerns with Packaging of ratio-PAROXETINE

Dear Health Care Professional,

ratiopharm Inc. (ratiopharm), following discussions with Health Canada, would like to inform you about concerns regarding the packaging of ratio-PAROXETINE in bottles. This concern does not affect the quality of ratio-PAROXETINE tablets. It is important to note these concerns present an extremely low risk to patients.

Potential for Stray Carvedilol Tablets in Bottles of ratio-PAROXETINE

There is a remote possibility that bottles of ratio-PAROXETINE (paroxetine hydrochloride) may contain a stray tablet of carvedilol. ratio-PAROXETINE packaged in blisters are not subject to this advisory. ratiopharm wants to emphasize that there have been no reported incidents of a carvedilol tablet being found in a bottle of ratio-PAROXETINE and this letter is being sent as a precautionary measure.

Please note that carvedilol, an alpha and beta blocking drug, is indicated for the treatment of mild, moderate or severe heart failure of ischemic or nonischemic origin. Carvedilol is contraindicated in patients with bronchial asthma and related bronchospastic conditions. Severe bronchospasm has been reported in some asthmatic patients exposed to a single dose of carvedilol.

The potential for an asthma patient to receive a stray carvedilol tablet is very remote, so it is very important that patients continue to take their current therapies as directed by their health care professionals and not discontinue treatment of ratio-PAROXETINE.

As an added precaution ratiopharm asks all pharmacies that use automatic dispensers (counting machines) to either manually dispense or visually inspect ratio-PAROXETINE from the batch numbers listed in the table below before providing them to their patients. There are significant differences in colour and shape, between carvedilol and ratio-PAROXETINE. Carvedilol tablets are white, film-coated, oval tablets.

ratio-Paroxetine Inventory as of March 21, 2005
Strength Lot Number Pack Size Pack Expiry Date
20mg X73P22 500's Bottle Jul. 2005
20mg X23P22 500's Bottle Jul. 2005
20mg X63P22 500's Bottle Jul. 2005
10mg X13P21 30's Bottle Jul. 2005
10mg FX13P21 30's Bottle Jul. 2005
20mg X13P22 100's Bottle Jul. 2005
20mg X33P22 100's Bottle Jul. 2005
20mg X43P22 100's Bottle Jul. 2005
20mg X53P22 100's Bottle Jul. 2005
30mg X23P23 30's Bottle Jul. 2005
30mg X13P23 30's Bottle Jul. 2005
20mg 14P22 500's Bottle Jan. 2006
20mg 24P22 500's Bottle Jan. 2006
20mg F44P22 500's Bottle Jan. 2006
20mg 44P22 500's Bottle Jan. 2006
20mg 34P22 100's Bottle Jan. 2006
20mg G44P22 100's Bottle Jan. 2006
20mg 54P22 500's Bottle Feb. 2006
20mg 64P22 100's Bottle Feb. 2006
30mg 34P23 30's Bottle Feb. 2006
30mg 14P23 30's Bottle Feb. 2006
20mg F94P22 500's Bottle Aug. 2006
20mg 94P22 500's Bottle Aug. 2006

If a pharmacist or any pharmacy personnel should discover a tablet of a different shape, size or colour than the medication being dispensed, he or she should contact the Customer Service Department of ratiopharm at 1-800-337-2584 immediately.

Please be assured that ratiopharm is working with Health Canada to resolve this issue as quickly as possible. ratiopharm has taken action to implement corrective measures. ratiopharm remains committed to product quality and patient safety, and we regret any inconvenience this temporary situation may cause. Should you have any further questions, please contact ratiopharm Customer Service at 1-800-337-2584.

The identification, characterization and management of drug-related adverse events are dependent on the active participation of health-care professionals in adverse drug reaction reporting programs. Healthcare professionals are asked to report any suspected adverse reactions in patients receiving ratio-PAROXETINE directly to ratiopharm or Health Canada at the following addresses:

ratiopharm inc.
6975 Creditview Road, Unit 5
Mississauga, Ontario
L5N 8E9
Tel: 1-800-337-2584

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) 957-0335
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

For other inquiries, please refer to contact information.
Drug Compliance Verification & Investigation Unit
DCVIU_UVCEM@hc-sc.gc.ca
Tel/Tél: (613) 941-3967
Fax/Téléc.: (613) 952-9805

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.

Sincerely,

original signed by

Kent Major
Vice-President, Development Management & Government Affairs
ratiopharm Inc.

[Text of letter ends]