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Type I Product Recall of Propofol Injection, 1 g/100 mL and 500 mg/50 mL Due to the Presence of Particulate Matter - Hospira Healthcare Corporation - For Health Professionals

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Contact: Health Products and Food Branch Inspectorate (HPFBI)

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

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

Health Canada Endorsed Important Safety Information on Propofol Injection (10mg/mL)

October 27, 2009

Subject: Type I Product Recall of Propofol Injection, 1g/100mL and 500mg/50mL due to the presence of particulate matter

Dear Health Care Professional,

Hospira Healthcare Corporation is bringing to your immediate attention a recall of two lots of Propofol Injection, 1g/100mL, lot 79834DJ & 500 mg/50mL, lot 79883DJ, (DIN: 02236887, expiry date: 2012/07/01) that was initiated on October 14, 2009 and classified as a TYPE I risk as per Health Canada's recommendation due to the presence in the propofol vials of particulate matter identified as stainless steel. These lots were distributed to hospitals starting in October 2009.

Hospira has not received any reports of adverse events associated with Propofol from its customers.

Hospira has initiated this voluntary recall because some of the vials may contain particulate matter. The particulate matter has been identified as stainless steel from equipment used in the manufacturing process. The investigation is complete and corrective actions have been implemented.

All hospitals who have received the two affected lots were individually contacted to initiate the quarantine and return of the affected products. This communication is intended to raise health professional awareness regarding potential complications that may occur following the use of affected propofol in order to monitor patients closely and treat them appropriately in a timely fashion.

"Propofol is an intravenous hypnotic agent for use in the induction and maintenance of general anesthesia or sedation for inpatient and outpatient surgery. Propofol is also indicated for pediatric anesthesia in children 3 years of age or older. It may also be used for sedation during diagnostic procedures and should only be administered to intubated, mechanically ventilated patients in the Intensive Care Unit (ICU) to provide continuous sedation and control of stress responses."(CPM, Propofol injection 10mg/mL. December 3, 2004; page 6.)

Generally, infused intravenous particulate matter known to exist in large numbers per given volume and/or with particulate characteristics of large size, jagged external morphology or aggregating properties, is acutely capable of direct mechanical damage on entry to the body (e.g. phlebitis), sub-acute and escalating damage to the body through the Systemic Inflammatory Response Syndrome (SIRS) cascade and/or chronic granuloma formation in the lungs. While it is understood that some risk mitigation is provided by the gauge (diameter) of the injecting needle not allowing aggregated particulate to be injected, there remains a concern over the sheer volume of particulate matter and the unique characteristics of this particulate matter. Whether an acute, sub-acute or combined injury, the presentation could be of a critical/permanent nature or even fatal.

A Systemic Inflammatory Response Syndrome (SIRS) is an inflammatory state affecting the whole body, frequently in response to infection or foreign body material infused or inhaled. Localized inflammation is a physiological protective response which is generally tightly controlled by the body at the site of injury. Loss of this local control or an overly activated response results in an exaggerated systemic response which is clinically identified as systemic inflammatory response syndrome.

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 Injection (10 mg/mL) should be reported to Hospira Healthcare Corporation or Health Canada at the following addresses:

We apologize for any inconvenience this action may cause.

Sincerely,

original signed by

Beryl Chan
Regional Director, Quality and Regulatory Affairs
Hospira Healthcare Corporation