Important Safety Information on Sodium Phosphates Injection - Notice to Hospitals

Starting date:

September 19, 2007

Posting date:

September 27, 2007

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170001705

This is duplicated text of a letter from Pharmaceutical Partners of Canada.

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 Sodium Phosphates Injection

September 19, 2007

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments and the Hospital Pharmacy, and other involved professional staff and post this NOTICE in your institution.

Subject: Recall of Sodium Phosphates Injection, USP due to Out of Specification Result for Aluminum Content. Lot 401239

Your institution has been identified as one that likely has received the recalled product lot 401239.

• Due to the out of specification result for aluminum content with this specific lot, there is potential for exposure to levels of aluminum higher than that advised on the label.

This product was brought into Canada under the Special Access Programme and is not a Canadian marketed product from Pharmaceutical Partners of Canada. The fabricator, Abraxis Pharmaceutical Products has notified us to recall this lot due to an Out of Specification result for Aluminum Content at the 21 month stability test station performed in June 2007. The average of values obtained at the 21 month station was 9692 mcg/L (11,531 mcg/L being the highest value), which exceeded the limit of NMT 9100 mcg/L, which is also the labeled amount. The product was made available through the SAP from October 2006 to December 2006, which corresponded to months 13 through 15 in the life of the product. The following aluminum values (averages) may therefore be of interest: 12 month station: 8558 mcg/L (average), 15 month station: 10,502 mcg/L, 18 month station: 8618 mcg/L.

In order to assess the potential clinical impact of this aluminum level, calculations were conducted on a hypothetical 3 kg neonate (the highest risk population affected by high aluminum levels) requiring 4 mEq/kg/day of sodium. The Sodium Phosphate Injection contains 4 mEq/mL sodium. Thus 3 mL of the injection would be required for this dose. Based on the highest amount of aluminum in the drug product at the 21 month period and a 3 mL dose, the total amount of aluminum administered would be 34.6 mcg instead of the 27.3 mcg as per the specification. A difference of 7.3 mcg aluminum/day.

It is unclear what the effect of this additional amount of aluminum would be, but healthcare professionals may consider this to be clinically significant in certain high risk patients.

Since there is a potential for harm due to this increased amount of aluminum, a Class II recall was initiated on August 17, 2007.

Patients who may have received this lot, since the affected product began distribution on October 17, 2006, should be assessed and their records evaluated to determine the amount of aluminum exposure and whether any adverse drug events were noted subsequent to receiving this product. If you wish more information on the levels of aluminum present at the time of use, please contact Pharmaceutical Partners of Canada at the number below. If you wish to have more information on aluminum levels in TPN or toxicity of aluminum, the references listed below are available upon request. In addition, Health Canada's website may provide useful information on aluminum.

We ask that any adverse drug events be reported to Pharmaceutical Partners of Canada or Health Canada at the following addresses.

Philip Hoy, Director Quality Assurance/Quality Control

Pharmaceutical Partners of Canada

A Division of Abraxis BioScience Inc.

45 Vogell Road, Suite 200

Richmond Hill, ON, L4B 3P6

Tel: 905-770-3711

Fax: 905-770-4811

Email: phoy@abraxisbio.com

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

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.

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

Special Access Programme

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

Tel.: 613-941-2108

Fax: 613-941-3194

Sincerely,

original signed by

Jim Walker

Vice President Scientific Affairs

Pharmaceutical Partners of Canada

A Division of Abraxis BioScience Inc.