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Health professional risk communication

Dexamethasone Sodium Phosphate Injection USP (dexamethasone phosphate) 10mg/mL - Recall of One Lot Due to Presence of Visible Particles in Some Vials - Notice to Hospitals

Starting date:
April 16, 2013
Posting date:
April 18, 2013
Type of communication:
Notice to Hospitals
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-26803

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

NOTICE TO HOSPITALS - Health Canada Endorsed Important Safety Information on Dexamethasone Sodium Phosphate Injection USP

April 16, 2013

Dear Healthcare Professional,

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

Subject: Recall of one lot of Dexamethasone Sodium Phosphate Injection USP (dexamethasone phosphate) 10mg/mL (DIN 00874582) due to presence of visible particles in some vials.

Dexamethasone is a synthetic glucocorticoid used principally as an anti-inflammatory or immunosuppressant drug.Footnote 1

Sandoz Canada Inc. has initiated a voluntary recall of one lot of Dexamethasone Sodium Phosphate Injection USP 10 mg/mL (lot CH1607 (expiry: 02/2015)) due to the observation of visible particulate matter in some vials of this lot. The particles are pale in color and look like crystal agglomerates. The sizes of the particles vary from 10µm x 10µm to 200µm x 100µm. This lot was distributed in Canada between March 30, 2012 and December 06, 2012.

It is to be noted that:

  • Particles have been observed in some vials of one lot of Dexamethasone Sodium Phosphate Injection USP 10 mg/mL. In the event where particulate matter is injected into a patient, there is potential for patient injury. Patients who are already ill are at higher risk of adverse effect. Footnote 2
  • Vials from the affected lot should not be used and should be returned to Sandoz.
  • Patients that would have received solution Dexamethasone Sodium Phosphate Injection USP from lot CH1607 (expiry: 02/2015) should be closely monitored for any cases of serious adverse reaction or unexpected adverse reactions. Patients should be treated accordingly.

Inadvertent injection of particulate matter could result in local inflammation, phlebitis, allergic response and/or embolization in the body. Since the release of the concerned lot of Dexamethasone Sodium Phosphate Injection USP 10 mg/mL, no adverse event reports were received at Sandoz Canada Inc.

Dexamethasone Sodium Phosphate Injection USP may be given by IV or IM injection when oral therapy is not feasible.Footnote 1

Corticosteroid administration may produce systemic as well as local effects.Footnote 1

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

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 unexpected adverse reactions in patients receiving Dexamethasone Sodium Phosphate Injection USP should be reported to Sandoz Canada Inc. or Health Canada.

Sandoz Canada Inc.
145, Jules Leger Street
Boucherville, Qc
J4B 7K8
Canada

Fax: 450-641-3621
Email: medinfo@sandoz.com

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

For other health product inquiries related to this communication, please contact Health Canada at:
Health Product 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 any question regarding the above information, please contact our Drug Information Department at 1-800-343-8839 (4636).

original signed by

Len Arsenault
Vice-President, Scientific Affairs
Sandoz Canada Inc.

Simona Surdila
Vice-President, Quality Unit
Sandoz Canada Inc.

References:

Footnotes

 

Sandoz Canada Inc., Dexamethasone Sodium Phosphate Injection USP, Prescribing Information, date of revision: 14-Jul-2011.

Return to footnote 1 referrer

 

Puntis JW and al, Hazard of Parenteral Treatment: do Particles Count?, accessed on 28-Mar-2013.

Return to footnote 2 referrer