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Important Safety Information on Sodium Phosphates Injection - Notice to Hospitals

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Contact SAP Drugs

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.

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.

Sincerely,

original signed by

Jim Walker
Vice President Scientific Affairs
Pharmaceutical Partners of Canada
A Division of Abraxis BioScience Inc.

References:
1. Brine E and Ernst J. Total Parenteral Nutrition for Premature Infants. NBIN. 2004;4(3):133-155.
2. Canada TW. Aluminum exposure through parenteral nutrition formulations: Mathematical versus clinical relevance. Am J Health-Syst Pharm. 2005;62:315-318.
3. Klein GL. Aluminum in parenteral solutions revisited-again. Am J Clin Nutr. 1995;61:449- 456.
4. Klein GL et al. Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition: Response to the Food and Drug Administration Notice of Proposed Rule by the North American Society for Pediatric Gastroenterology and Nutrition. JPGN. 1998;27(4):457-460.
5. Klish WJ et al. Aluminum Toxicity in Infants and Children. Pediatrics. 1996;97(3):413-416.
6. Smith BS et al. Effect of Additive Selection on Calculated Aluminum Content of Parenteral Nutrition Solutions. Am J Health-Syst Pharm. 2007;64(7):730-739.