Other safety alerts
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| The United Kingdom: Class 4 Drug Alert: Printed box error which potentially affects all plastic boxed Pre Filled Syringes supplied by Aurum (trading as Martindale Pharma) |
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Further to the Class 4 Drug Alerts issued in November 2011, Aurum Pharmaceuticals Limited (trading as Martindale Pharma) has informed the MHRA of another incident related to incorrect screen printing on a plastic box containing a pre-filled syringe. The new incident concerns a blue plastic box where the screen printed box label on the longest panel incorrectly states “Atropine 3mg/10mls”. The label on the syringe and paper tamper-evident label on the end of the plastic box states “Calcium Chloride 10%” and the MHRA believes these labels are correct. The batch number is 7005481 and the expiry date is 10/2014. The MHRA is advising recipients to inspect all boxes of pre-filled syringes from Aurum Pharmaceuticals Limited (trading as Martindale Pharma) irrespective of product and box colour. If there is any mismatch between the screen printed box label on the longest panel and paper tamper-evident label on the box end, the box should be immediately withdrawn from stock and returned to the original supplier. These products have not previously been recalled due to a critical supply issue. In view of the nature of the risk and recurrence of this issue the MHRA may issue additional advice next week to recall products and source from alternative suppliers.
Please refer to the following website in the MHRA for details:
http://www.mhra.gov.uk/Publications/Safetywarnings/DrugAlerts/CON149654
In Hong Kong, the above product is not a registered pharmaceutical product. The drug alerts regarding printed box error of Aurum Pharmaceuticals Limited have been released by the MHRA and were posted on the website of Drug Office on 12 November 2011 and 22 November 2011.
Ends/Tuesday, April 10, 2012
Issued at HKT 12:30
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