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Sandoz Morphine Sulfate Injection USP 2mg/mL (1mL) Some Boxes May Contain Ampoules Labelled as Isoproterenol Hydrochloride Injection - For Health Professionals
- Starting date:
- January 1, 2012
- Type of communication:
- Advisory
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Audience:
- Healthcare Professionals
- Identification number:
- RA-170002659
Advisory details
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Notice about Health Canada advisories
Health Canada Issued Important Safety Information on Sandoz Morphine Sulfate Injection USP
March 21, 2012
To: Medical Clinics and Pharmacies
Please distribute to all healthcare professionals
Subject: Urgent Notice – 2mg/mL (1mL) Sandoz Morphine Sulfate Injection USP – Some boxes may contain ampoules labelled as Isoproterenol Hydrochloride Injection in addition to ampoules labelled as containing morphine
Health Canada is urgently informing healthcare professionals that it has been advised by Sandoz Canada Inc. that one package of 2mg/mL (1mL) Morphine Sulfate Injection USP has been found to contain ampoules labelled as 0.2 mg/mL (1mL) Isoproterenol Hydrochloride Injection in addition to ampoules labelled as containing morphine.
Sandoz Canada became aware when a hospital reported discovering ampoules labelled as 0.2 mg/mL (1mL) Isoproterenol Hydrochloride Injection USP improperly packaged in a box labeled as containing 2mg/mL (1mL) ampoules of Morphine Sulfate Injection USP. The box contained ampoules labelled as morphine as well as ampoules labelled as isoproterenol hydrochloride. A photo is provided below and is also available on the Health Canada website.
Healthcare professionals are advised to immediately quarantine any supply of products from the lots specified below until further notice.
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.
At this time, Sandoz Canada has indicated to Health Canada that it cannot confirm whether other similar packages exist. Health Canada is working urgently with Sandoz Canada to determine the scope of the issue, and to ensure that other incorrectly packaged product, if any, does not make it into the drug supply system. Health Canada has also informed provinces and territories. New information will be communicated to healthcare professionals as appropriate.
AFFECTED PRODUCTS:
Morphine Sulfate Injection USP
2mg/mL 1mL
DIN 2242484
UPC 057513056420
Lot CC2824 exp. 2014-12
Isoproterenol Hydrochloride Injection USP
0.2 mg/mL 1mL
DIN 897639
UPC 057513046001
Lot CB8787 exp. 2012-11
For health product inquiries related to this communication, please contact Health Canada at:
Health Products and Food Branch Inspectorate
Telephone (toll-free): 1-800-267-9675