UPDATE: Sandoz Canada recalling partial lot of 2 mg/mL (1 mL) Morphine Sulfate Injection

Starting date:

March 22, 2012

Posting date:

March 22, 2012

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product Safety, Labelling and Packaging

Audience:

Healthcare Professionals, Hospitals

Identification number:

RA-110005559

• Issue
• What you should do
• Who is affected
• Background
• Report health or safety concerns
• Media enquiries
• Public enquiries
• What Health Canada is doing
• Images

Issue

Note that updated information regarding the quarantine of one lot of Isoproterenol Hydrochloride Injection USP was added to this advisory on March 26, 2012.

Following our March 21, 2012, Notice to Hospitals and Notice to Healthcare Professionals, Health Canada is advising Canadians that Sandoz Canada Inc. will be voluntarily recalling a portion of one lot of 2 mg/mL (1 mL) Morphine Sulfate Injection (Lot CC2824 exp. 2014-12) from the Canadian market. The recall applies to all products that has been distributed to healthcare providers.

The recall is in light of a report from a Toronto hospital that found one box labelled as morphine ampoules (vials) incorrectly contained ampoules of isoproterenol.

Sandoz has remaining inventory of the affected lot, which has not been distributed. In light of current supply constraints and to minimize the impact on Canadians, Sandoz Canada is currently inspecting its inventory of morphine packages from the affected lot to confirm that all of the morphine packages contain the correct product. Once Sandoz Canada has verified that all of the packages contain the correct product, the inventory will be clearly marked to indicate it has been inspected and can be released on the market. Products that are currently in distribution and that are being recalled will not be re-released.

Healthcare professionals and Canadians are also advised that, further to our March 21 Notices, the quarantine of one lot of 0.2 mg/mL (1 mL) Isoproterenol Hydrochloride Injection USP (Lot CB8787 exp. 2012-11) has been lifted. Healthcare facilities with this product in stock are advised that product from this lot can be released for use as appropriate.

What you should do

• For information concerning the recall or how to return the affected product, contact Sandoz Canada directly, toll-free, at 1-877-650-0751
• Be aware that the quarantine on 0.2 mg/mL (1 mL) Isoproterenol Hydrochloride Injection USP (Lot CB8787 exp. 2012-11) has been lifted and can be released for use as appropriate.
• Submit complaints regarding the safety, efficacy or quality of health products to Health Canada's Inspectorate, toll-free, at 1-800-267-9675.
   

Who is affected

Healthcare professionals, hospitals, clinics and other health institutions that may have supply of the recalled product in stock.

Background

Inadvertent use of Isoproterenol Hydrochloride Injection USP instead of Morphine Sulfate Injection USP can result in serious health effects. Patients will not receive the intended morphine therapy. As well, Isoproterenol Hydrochloride is a powerful adrenergic agent. It is associated with a risk of tachycardia and arrhythmia, which may be life threatening. Other side effects may include headache, tremor and sweating.

The recalled product is as follows:

Morphine Sulfate Injection USP
2 mg/mL (1 mL)
Lot CC2824 exp. 2014-12
DIN 02242484
UPC 057513056420

Report health or safety concerns

To report suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

• Fax: 1-866-678-6789
• E-mail: CanadaVigilance@hc-sc.gc.ca
• Internet: MedEffect Canada
• Mail: Canada Vigilance Program
  Marketed Health Products Directorate
  Ottawa, ON, Address Locator 0701C
  K1A 0K9

Media enquiries

613-957-2983

Public enquiries

613-957-2991
1-866-225-0709

What Health Canada is doing

On March 21, Health Canada issued a Notice to Hospitals and Notice to Healthcare Professionals, advising that product from the affected lots should be quarantined until further notice.

Health Canada is now advising that a portion of the affected lot of morphine (Lot CB8787 exp. 2012-11) is being recalled, and that the quarantine on the one lot of isoproterenol hydrochloride (Lot CB8787 exp. 2012-11) has been lifted.

Health Canada is monitoring the voluntary recall of morphine and will continue to work closely with Sandoz Canada.

The Department continues to provide updated information to provinces and territories, and will communicate new information to Canadians, as appropriate.

Health Canada has not received any reports of patient harm involving this packaging error.

Images

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