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The Department of Health (DH) today (October 11) endorsed Roche Hong Kong Limited (Roche) , a licensed drug wholesaler, to conduct a voluntary recall of six registered pharmaceutical products namely Rocephin for Inj 250mg IM (HK-20182), Rocephin for Inj 500mg IM (HK-20187), Rocephin for Inj 500mg IV (HK-20188), Rocephin for Inj 1g IV (HK-20190), Rocephin for Inj 1g IM (HK-20192) and Rocephin for Inj 250mg IV (HK-52844) because of a stability issue.
A DH spokesman said that Roche informed the DH today, that during an ongoing stability study, the Swiss manufacturer, F. Hoffmann-La Roche Ltd, found that two batches of Rocephin for Inj 250mg IV (Batch No. B1132 and B1133) were out of specification (OOS) for degradation product at the 30-month time point under the condition of 30 degree Celsius and 75 per cent relative humidity. The registered shelf life of the products is 36 months. According to the manufacturer, the OOS might be related to the closure system of the injection vial. The root cause of the OOS is being investigated by the manufacturer.
Based on the information available so far, the effect of this OOS on the safety and efficacy of the products is very low. The DH has requested Roche to provide a detailed investigation report on the cause of the incident. The DH's investigation is continuing.
Only one affected batch of Rocephin for Inj 250mg IV (Batch No. B1132B01) had been imported to Hong Kong in February 2011. A total of 330 vials of this affected batch had been imported and they were all used. The DH has not received any adverse report in connection with this batch. As a precautionary measure, Roche is conducting a total recall of all Rocephin Injections.
Rocephin Injections had been supplied to the Hospital Authority, private hospitals, private doctors and pharmacies and exported to Macau.
Rocephin Injections contain the antibiotic ceftriaxone and are prescription medicines.
Roche has set up a hotline at 2733 4610 to answer related enquiries. The DH will closely monitor the recall.
"Members of the public who have been given the injections should consult their healthcare professionals if in doubt or feeling unwell," the DH spokesman said.
Ends/Thursday, October 11, 2012
Issued at HKT 20:29
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