The Department of Health (DH) today (March 29) endorsed the recall by Novartis Pharmaceutical (HK), a licensed drug wholesaler, of all batches of its Carboplatin 10mg/ml Injection (Ebewe) (registration number: HK-43913) from shelves as part of an international effort to curb quality failure in the product.
A DH spokesman said that today Novartis gave notification that the above product's Austrian manufacturer, Ebewe Pharma, had decided to recall the product as a precautionary measure because precipitates were identified in several batches of samples retained routinely as part of good manufacturing practice.
"According to Ebewe Pharma, the precipitates are likely from either the active drug ingredient or its degradation. Further, preliminary assessment indicated that the precipitates are probably the result of stability issues, although the root cause remains to be identified. Hence, the DH's investigation is to continue," the spokesman said.
The spokesman explained that the health concern is that precipitates' presence in injectable products may pose risks including granulomas or even vascular occlusions.
Carboplatin 10mg/ml Injection (Ebewe) is indicated for the treatment of various cancers. It can only be sold on prescription and under the supervision of pharmacists at registered dispensaries.
"It is reassuring at this stage that the DH has not received any adverse report in connection," the spokesman said.
According to Novartis, the product came in 15ml and 45ml vials which were supplied to hospitals of the Hospital Authority, private hospitals and private doctors, and also exported to Macau. Therefore, the DH has also informed these parties about the recall.
Novartis has set up a hotline at 2881 5811 to answer related enquiries.
"Here, contravention of the Public Health and Municipal Ordinance (Cap 132), selling a drug not of the nature, substance or quality demanded by the purchaser, might have occurred. The maximum penalty involved is a fine of $10,000 and three months' imprisonment. The DH will seek the Department of Justice's advice on completion of our investigation," the spokesman said.
"Health-care professionals who have the product in hand should surrender it to the DH's Drug Office at 3/F, Public Health Laboratory Centre, 382 Nam Cheong Street, Kowloon, during office hours for disposal, or return the product to the supplier. Moreover, members of the public who have been given the product should consult their health-care providers if in doubt or feeling unwell," the spokesman added.
(Reprinted from HKSAR Government web page
http://www.info.gov.hk/gia/general/201203/29/P201203290388.htm )