Sandoz Morphine Sulfate Injection USP 2mg/mL (1mL) - urgent Recall Notice - For Health Professionals

Starting date:

March 24, 2012

Posting date:

March 30, 2012

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170002644

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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

Health Canada Endorsed Important Safety Information on Morphine Sulfate Injection USP 2 mg/mL, 1 mL ampoule

March 24, 2012

Dear Health Care Professional,

Subject: URGENT - Recall of one lot of Morphine Sulfate Injection USP 2mg/mL, 1 mL ampoule

Sandoz Canada is voluntarily initiating an immediate recall of a portion of lot CC2824 / exp. 2014-12 of Morphine Sulfate Injection USP 2 mg/mL, 1 mL ampoule (Sandoz Code: 5642). The recall applies to all products that have been distributed to healthcare providers. This recall is being initiated because of the potential presence of ampoules of Isoproterenol HCl Injection USP 0.2 mg/mL in boxes of Morphine Sulfate Injection USP 2 mg/mL, 1 mL ampoule. All units in your possession should be returned following the instructions of your wholesaler or distributor for narcotic products.

Morphine Sulfate Injection USP, used with or without dilution, is indicated exclusively for the symptomatic relief of moderate to severe pain.^Footnote1 Inadvertent use of Isoproterenol Hydrochloride instead of Morphine Sulfate Injection USP can result in serious health effects. Isoproterenol Hydrochloride Injection USP is a sympathomimetic agent which is associated with a risk of tachycardia and arrhythmia, which may be life-threatening. Other side effects include headaches, mild tremors and sweating.^Footnote2

• Labels of Isoproterenol Hydrochloride Injection USP 0.2 mg/mL and Morphine Sulfate Injection USP 2 mg/mL are very different in color: labels of morphine are lime green and grey whereas labels of isoproterenol are blue and red;
• All ampoules are correctly labelled: this means that ampoules labelled morphine contain morphine and that ampoules labelled isoproterenol contain isoproterenol;
• Only lot CC2824 exp. 2014-12 of Morphine Sulfate Injection USP 2 mg/mL, 1 mL ampoule is affected by this recall. No replacement lot of this product is available from Sandoz at the present time, however, Sandoz is working to resupply the market as soon as possible.

Supply

Because of current supply issues, Sandoz, in collaboration with Health Canada, has identified a solution to minimize the impact of this recall on product access. As agreed with Health Canada, Sandoz will perform a 100% visual verification of the inventory which remains within its control, and clearly mark each inspected box with a round, green sticker bearing the words "SANDOZ, Inspected, Lot, Approved." An example of this sticker is illustrated below.

Sandoz recommends that all pharmacists contact their patients to whom they have dispensed this product. Patients should be advised to consult their healthcare professional if they have used this product and are concerned about their health.

The use of Isoproterenol Hydrochloride Injection USP is contraindicated in patients with tachyarrhythmias, tachycardia of heart-block caused by digitalis intoxication, ventricular arrhythmias which require inotropic therapy and angina pectoris.^Footnote2

In case of accidental overdosage of Isoproterenol Hydrochloride as evidenced mainly by tachycardia or other arrhythmias, palpitations, angina, hypotension, or hypertension, use should be discontinued and blood pressure, pulse, respiration, and ECG monitored. It is not known whether isoproterenol is dialysable.^Footnote2

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-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious or unexpected adverse reactions in patients receiving Morphine Sulfate Injection USP 2 mg/mL should be reported to Sandoz Canada Inc. or Health Canada.

Sandoz Canada Inc.
145 Jules Léger
Boucherville, Quebec, Canada
J4B 7K8
Tel: 1-800-343-8839 ext. 4636
Fax: 1-888-243-6221

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at MedEffect™ Canada
• Call toll-free at 1-866-234-2345
• Complete a Reporting Form and:
  • Fax toll-free to 1-866-678-6789, or
  • Mail to:
    Canada Vigilance Program
    Health Canada
    Postal Locator 0701E
    Ottawa, Ontario K1A 0K9

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section. The Reporting Form is also in the Canadian Compendium of Pharmaceuticals and Specialties.

For other health product inquiries related to this communication, please contact Health Canada at:
Drug Compliance Verification and Investigation Unit - Health Products and Food Branch Inspectorate
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-267-9675

To change your mailing address or fax number, contact the Market Authorization Holder (Industry).

Patients are our top priority and we remain committed to ensuring the quality and safety of all products. We apologize for any inconvenience which this situation may cause.

Sincerely yours,

original signed by

Leonard J. Arsenault
Vice-President, Scientific Affairs

Simona Surdila
Vice-President, Quality Unit