Other safety alerts
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| Quality Defect of Timentin® (ticarcillin-clavulanate): Cracked vials |
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GlaxoSmithKline Limited (GSK), a licensed drug wholesaler, informed the Department of Health (DH) about a low incidence quality defect of Timentin® (ticarcillin-clavulanate). An investigation at the GSK Worthing UK manufacturing site has identified a low incidence of cracked vials used in multiple finished batch lots of Timentin®. A formal investigation is currently ongoing at the manufacturing site. GSK has informed the UK Medicines and Healthcare Products Regulatory Agency (MHRA), and MHRA have agreed that it is appropriate to alert Healthcare Professionals who administer the antibiotic to this issue. No further market action is required. This product has been on global rationing since late 2011, and as such overall market stocks are low. The stock is being carefully managed by GSK to minimize patient impact of this shortfall in supply. The cracked vial defect has the potential to breach the integrity of the vial. In the event of the integrity of the vial being breached the antibiotic powder may be subject to discolouration prior to or upon reconstitution. As a precaution, GSK advise healthcare professionals to inspect the integrity of the vial before use. If they observe any damage to the glass that looks like a crack then do not use the vial and return to GSK. Besides, healthcare professionals is advised to administer the product only if it presents as a pale or straw coloured liquid upon reconstitution.
In Hong Kong, Timentin for IV Infusion 3.2G (HK-30366) is registered by GSK and it is a prescription only medicine. Regarding this issue, GSK informed DH that they will issue a “Dear Healthcare Professional Letter” to inform healthcare professionals about the incident today. DH will keep vigilant on the above issue.
Ends/Wednesday, October 22, 2014
Issued at HKT 16:00 |
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