Press Release

Batch recall of Irinotecan Concentrate for Infusion 100mg/5ml

10 September 2012

The Department of Health (DH) today (September 10) endorsed the recall of one batch of Irinotecan Concentrate for Infusion 100mg/5ml (Irinotecan)(Registration number: HK-54038) from the market by a licensed drug wholesaler, Hospira Limited (Hospira), because of a quality issue.

A DH spokesman said that Hospira informed the DH today of a global recall of two batches (Batch numbers: Y073775A and Y083775A)of Irinotecan. The Australian manufacturer has received 4 complaints in Europe, 1 related to batch Y073775A and 3 related to batch Y083775A, relating to breakage at the neck of the vial upon handling. This might pose a potential of injury to health professionals during handling and affect the sterility of the product. After thorough review of all batch records, an out of trend for breakages was identified for these two batches. The root cause of breakage was due to an excessive capping head pressure applied during the capping and crimping processes in the manufacture of these two batches.

Only one of the recalled batches had been imported into Hong Kong. The batch number is Y073775AA(repacked from Y073775A). A total of 3240 vials from this batch had been imported in December 2011 and all were supplied to the Hospital Authority.

The DH has requested Hospira to provide a detailed investigation report on the cause of the incident. The DH's investigation is continuing.

Irinotecan is an anti-cancer drug manufactured in Australia. It can only be sold on prescription and under the supervision of pharmacists at registered dispensaries.

The DH has not received any adverse report in connection with the product.

Hospira has set up a hotline at 2898 2886 to answer related enquiries. The DH will closely monitor the recall.

"Members of the public who have been using the product should consult their health-care providers if in doubt or feeling unwell," the DH spokesman said.

The Department of Health today (September 10) endorsed the recall of one batch of Irinotecan Concentrate for Infusion 100mg/5ml (registration number: HK-54038) from the market by a licensed drug wholesaler, Hospira Limited, because of a quality issue.