Baxter Calcium-45, 24 EA/CA - Recall of One (1) Lot Due to Missing Bottle Labels - Notice to Hospitals

Starting date:

September 20, 2014

Posting date:

September 21, 2014

Type of communication:

Notice to Hospitals

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information, Labelling and Packaging

Audience:

Healthcare Professionals

Identification number:

RA-41501

This is duplicated text of a letter from Baxter Corporation. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

NOTICE TO HOSPITALS - Health Canada Endorsed Important Safety Information on Calcium-45, 24 EA/CA

September 20, 2014

Dear Renal Program Manager, Director of Nephrology and Director of Dialysis Unit,

Please distribute to relevant Departments (Nephrology, Pharmacy, Paediatrics, Internal Medicine, Nursing, Intensive Care and/or other Departments as required, Dialysis Unit and Dialysis Clinics associated with your hospital), other involved professional staff and post this notice in all relevant areas of your institution.

Subject: Recall of one (1) lot of Baxter Calcium-45, 24 EA/CA (DIN: 02160986) due to Missing Bottle Labels (Product Code: CA50, Lot Number: W4A07S0)

Baxter Corporation in consultation with Health Canada has initiated an Urgent Product Recall for one (1) lot of Calcium-45, 24 EA/CA, due to missing bottle labels. The affected lot (Lot Number: W4A07S0) has been distributed in Canada between February 07, 2014 and April 24, 2014. 

Calcium-45 is used as an additive for creating the prescribed calcium concentration for dialysate used for hemodialysis treatments.

• There is a potential risk of medication error and patient harm if an unlabelled product is administered to a patient.  
• Medication error could include use of a different than intended concentration of Calcium-45. A higher than intended concentration of calcium could cause hypercalcemia resulting in cardiac arrhythmias, hypertension, lethargy, coma or changes in mental status.
• Healthcare professionals should NOT use any products from the affected lot. Affected inventory should be quarantined and returned to Baxter.

Baxter is recalling the following Calcium additive lot.

Description: Calcium-45, Product Code: CA50, Lot Number: W4A07S0

The specified lot should not be used. Contact Baxter Customer Care at 1-888-719-9955 to arrange for return and credit of the affected lot number. Baxter is currently investigating this issue and has not received any reports of adverse events for the specified lot.

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-market adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse reactions in patients receiving Calcium-45 should be reported to Baxter or Health Canada.

Baxter Corporation

Mailing address:

Attn: Pharmacovigilance

7125 Mississauga Road

Mississauga, ON

L5N 0C2

Phone: 1-800-387-8399 ext 6607

E-Mail: canada_pharmacovigilance@baxter.com

Fax: 1-855-767-4573

To correct your mailing address or fax number, contact Baxter Customer Care at 1-888-719-9955.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

• Calling toll-free at 1-866-234-2345, or
  
   
• Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, contact Health Canada at:

Health Products and Food Branch Inspectorate

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

Telephone: 1-800-267-9675

Fax: 613-946-5636

For questions related to the return of affected Calcium-45, (Product Code: CA50, Lot Number: W4A07S0), please contact Baxter Customer Care at 1-888-719-9955.

Sincerely,

original signed by

Danielle Tokarski

Quality Systems Manager

Baxter Corporation