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| |  Ultiva (Remifentanil hydrochloride) Recalled in Canada Due to Potential for Overdose OTTAWA, CANADA -- December 28, 2007 -- Abbott Laboratories, Limited (Abbott), in consultation with Health Canada, has initiated a recall on certain lots of Ultiva® 1 mg vials due to a printing defect that could potentially lead to a 10-fold overdose of Ultiva. A printing defect identified on a limited number of Ultiva 1 mg vial labels could result in a 10-fold overdose of Ultiva if the strength is misinterpreted as 0.1 mg instead of 1 mg. The printing defect is limited to the following Ultiva 1 mg vial lots: 49290DD, 52185DD and 56275DD. The printing defect does not affect the Ultiva 2 mg vials. Please note that an Ultiva 0.1 mg vial does not exist. The printing defect on a limited number of Ultiva 1 mg vial labels consists of a small area where ink was not transferred onto the label. This defect, the size of a decimal point, appears on certain labels directly before the Ultiva strength (1 mg) and may be mistaken for 0.1 mg instead of 1 mg. In the interest of patient safety, Abbott has initiated a recall of Ultiva 1 mg lots 49290DD, 52185DD and 56275DD to the end-user level. This precautionary measure is being taken to reduce the risk of Ultiva overdose. To date, Abbott has not received any report of adverse reactions related to this printing defect. Ultiva (remifentanil hydrochloride) is indicated for IV administration as an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. According to the Product Monograph, overdosage with Ultiva (remifentanil hydrochloride), as with all potent opioid analgesics, would be manifested by an extension of the pharmacological actions of the drug. Expected signs and symptoms of overdosage include: apnea, chest-wall rigidity, seizures, hypoxemia, hypotension, and bradycardia. For additional information on treatment of Ultiva overdose, please refer to the Product Monograph. Abbott has initiated a recall to the end-user level and is organizing the return of the product in accordance with regulatory requirements for narcotics. Should you have affected vials on hand, please carefully follow the procedure in place in your institution. 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 occurrences of serious and/or unexpected adverse reactions or accidental overdose in patients receiving Ultiva should be reported to Abbott or Health Canada at the following addresses: Abbott Laboratories, Limited Any suspected adverse incident can also be reported to: The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties. For other inquiries related to this communication, please contact Health Canada at:
SOURCE: Health Canada
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