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Health professional risk communication

Propofol-II Injectable Emulsion 1%, (10mg/mL), 1000mg/100mL - Recall of Lot No. 29609DJ Due to Presence of Particulate Matter - For Health Professionals

Starting date:
November 27, 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-36999

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

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on Propofol-II Injectable Emulsion 1% (10mg/mL), 1000mg/100mL

November 27, 2013    

Dear Healthcare Professional,

Subject: Recall of Propofol-II Injectable Emulsion 1%, (10mg/mL), 1000mg/100mL (DIN: 02376865), Lot No. 29609DJ due to presence of particulate matter

Hospira Healthcare Corporation, in consultation with Health Canada, would like to inform you of a recall of one lot of Propofol-II Injectable Emulsion 1% (10 mg/mL) due to presence of particulate matter identified in one of the retained samples from one lot of Propofol-II (29609DJ) distributed in Canada.  The particulate matter was identified as iron oxide. Hospira has not received any complaints regarding the lot distributed in Canada.

“Propofol is an intravenous hypnotic agent for use in the induction and maintenance of general anesthesia or sedation for inpatient and outpatient surgery. Propofol-II is also indicated for pediatric anesthesia in children 3 years of age or older. It may also be used for sedation during diagnostic procedures in adults and should only be administered to intubated, mechanically ventilated, adult patients in the Intensive Care Unit (ICU) to provide continuous sedation and control of stress responses."(CPM, Propofol-II injection 10mg/mL. October 22, 2012; page 4.)

This lot of Propofol-II was distributed between June 2013 and August 2013 to customers.

  • Particles have been observed during inspection of one lot of Propofol-II Injection (10 mg/mL). Inadvertent injection of particulate matter could result in local inflammation, phlebitis, allergic response and/or embolization in the body.
  • Vials of the affected lot (29609DJ) should not be used and should be returned to Hospira.
  • Healthcare professionals are recommended to remain vigilant in their follow up of post-operative patients.

Hospira has not received any reports of adverse events associated with Propofol-II Injectable Emulsion 1% (10mg/mL) from its customers.

Hospira has initiated investigations to determine the root cause and corrective and preventive actions.

Product being recalled is listed below:
Description DIN Lot No. List Number  Expiry Date
Propofol -II Injectable Emulsion 1%, (10mg/mL) 1000mg/100mL  02376865 29609DJ 04699099 May 1, 2015

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 Propofol-II Injectable should be reported to Hospira Healthcare Corporation or Health Canada at the following addresses:

Hospira Healthcare Corporation
1111 Dr.-Frederik-Philips, Suite 600
Saint-Laurent (Québec) H4M 2X6
To report an Adverse Reaction, consumers and health professionals may call toll free :
Tel: 1-866-488-6088 Option 6
Fax: 1-877-906-0208
ProductcomplaintsCA@hospira.com

To correct your mailing address or fax number, contact: Hospira Healthcare Corporation.

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 and Product and Food Branch Inspectorate (HPFBI)
E-mail: DCVIU_UVECM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636.


Sincerely,

Original signed by

Rania Al-Ammar
Regional Director, Commercial Quality
Hospira Healthcare Corporation