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Phosphate Injectable Products - Potential for Particulate Matter in Some Vials - For Health Professionals

Starting date:
November 20, 2013
Posting date:
November 27, 2013
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-36839

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

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on Potassium Phosphates Injection USP, Potassium Phosphate Monobasic Injection and Sodium Phosphates Injection USP

November 20, 2013

Dear Health Care Professional,

Subject: Potential for Particulate Matter in Some Vials of Potassium Phosphates Injection USP 10 ml Vials (DIN: 00804789, Product Code: 6750), Potassium Phosphate Monobasic Injection 10 ml Vials (DIN: 00711306, Product Code: 6720) and Sodium Phosphates Injection USP 10 ml Vials (DIN: 00896187, Product Code: 7990)

Sandoz Canada Inc., in consultation with Health Canada, would like to inform you that particulate matter was observed in some vials of one lot of Potassium Phosphates Injection USP 10 ml vials that has not been released on to the Canadian market. Due to the potential for particulate matter in other sterile injectable sodium and potassium phosphate products, healthcare professionals are advised to use an in-line filter when administering any of these phosphate products. These products are distributed in Canada by Baxter. A list of potentially affected products and corresponding lot numbers are attached.

  • Particles have been observed in some vials of one lot of Potassium Phosphates Injection USP 10 ml vials that was not released on to the Canadian market. In the event where particulate matter is injected into a patient, there is potential for patient injury.
  • Carefully inspect all phosphate injectable products before and after dilution. If particulate matter is discovered, do not administer.
  • To minimize the risk for all phosphate injectable products, use a 5 micron filter needle to withdraw the required calculated volume and use a 0.22 micron in-line filter when administering the final IV admixture to patients.
  • ONLY for the administration of 3 in 1 parenteral nutrition solutions containing either sodium phosphate or potassium phosphate solutions, use of a 1.2 micron filter instead of a 0.22 micron filter, is recommended.

Potassium Phosphates Injection USP is indicated as a potassium supplement, Potassium Phosphate Monobasic Injection as an electrolyte supplement and Sodium Phosphates Injection USP as an electrolyte replenisher. These products are approved for intravenous administration after dilution.

Inadvertent injection of particulate matter could result in local inflammation, phlebitis, allergic response and/or embolization in the body. Since the release of the potentially affected phosphate injectable products, no adverse event reports related to this issue were received at Sandoz Canada Inc.

As a precautionary measure, all parenteral drug products should be inspected visually for the presence of particulate matter. Every container whose contents show evidence of visible particulates should not be used and should be reported to Sandoz Canada.

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 adverse reaction or other serious or unexpected adverse reactions in patients receiving Potassium Phosphates Injection USP, Potassium Phosphate Monobasic Injection or Sodium Phosphates Injection USP should be reported to Sandoz Canada Inc. or Health Canada.

Sandoz Canada Inc.
145 Jules Léger
Bouchervillle, Quebec, Canada
J4B 7K8
Tel: 1-800-343-8839 ext. 4636
Fax: 1-888-243-6221

To correct your mailing address or fax number, contact Sandoz Canada Inc.

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, please contact Health Canada at:
Health Products and Food Branch Inspectorate (HPFBI)
E-mail: DCVIU_UVECM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636

If you have questions regarding the above information, please contact our Drug Information Department at 1-800-343-8839 (4636). If you have questions regarding products availability, please call Baxter Customer Service at 1-888-719-9955.

Sincerely,

original signed by

Michèle Théberge
Vice-President, Quality Unit

Len Arsenault
Vice-President, Scientific Affairs

References:

  1. Puntis JW and al, Hazard of Parenteral Treatment: do Particles Count?, accessed on 28-Mar-2013
  2. Packaging of Potassium Phosphates Injection USP, Potassium Phosphate Monobasic Injection and Sodium Phosphates Injection USP
Appendix A
Baxter Product Code Product Description Lot number Expiry date
6750 POTASSIUM PO4 3MMOLP/ML 10ML 10LIVI CA BG4591 31/12/2013
6720 POTASSIUM PHO MONOBASIC 10ML 10LIVI CA BH9050 31/01/2014
6750 POTASSIUM PO4 3MMOLP/ML 10ML 10LIVI CA BL1261 28/02/2014
6720 POTASSIUM PHO MONOBASIC 10ML 10LIVI CA BS1390 31/05/2014
6750 POTASSIUM PO4 3MMOLP/ML 10ML 10LIVI CA BW8396 31/08/2014
7990 SODIUM PO4 3MMOLP/ML 10ML 10LIVI CA CB6612 30/11/2013
6720 POTASSIUM PHO MONOBASIC 10ML 10LIVI CA CB2566 30/11/2014
7990 SODIUM PO4 3MMOLP/ML 10ML 10LIVI CA CF3227 31/01/2014
7990 SODIUM PO4 3MMOLP/ML 10ML 10LIVI CA CC4793 31/12/2013
6750 POTASSIUM PO4 3MMOLP/ML 10ML 10LIVI CA CM2759 31/05/2015
6750 POSTASIUM PO4 3MMOLP/ML 10ML 10LIVI CA CC4869 31/12/2014
6720 POTASSIUM PHO MONOBASIC 10ML 10LIVI CA CD1657 31/12/2014
6720 POTASSIUM PHO MONOBASIC 10ML 10LIVI CA CF2454 31/01/2015
6720 POTASSIUM PHO MONOBASIC 10ML 10LIVI CA CH1609 31/03/2015
6750 POTASSIUM PO4 3MMOLP/ML 10ML 10LIVI CA CU9275 30/09/2015
6750 POTASSIUM PO4 3MMOLP/ML 10ML 10LIVI CA CV0423 30/09/2015
6750 POTASSIUM PO4 3MMOLP/ML 10ML 10LIVI CA CZ1458 30/11/2015
6750 POTASSIUM PO4 3MMOLP/ML 10ML 10LIVI CA DC0197 31/01/2016
7990 SODIUM PO4 3MMOLP/ML 10ML 10LIVI CA DA1733 31/12/2015
7990 SODIUM PO4 3MMOLP/ML 10ML 10LIVI CA CZ4425 30/11/2015
7990 SODIUM PO4 3MMOLP/ML 10ML 10LIVI CA DB8315 31/01/2016
7990 SODIUM PO4 3MMOLP/ML 10ML 10LIVI CA DC1368 31/01/2016
6720 POTASSIUM PHO MONOBASIC 10ML 10LIVI CA DF5688 31/03/2016
7990 SODIUM PO4 3MMOLP/ML 10ML 10LIVI CA DG1641 31/03/2016
6720 POTASSIUM PHO MONOBASIC 10ML 10LIVI CA DG2451 31/03/2016
6750 POTASSIUM PO4 3MMOLP/ML 10ML 10LIVI CA DC0197 31/01/2016
7990 SODIUM PO4 3MMOLP/ML 10ML 10LIVI CA DG5193 31/03/2016