Aurum Pharmaceuticals Limited (trading as Martindale Pharma)

Printed box error which potentially affects all yellow boxed Pre Filled Syringes supplied by Aurum  

Adrenaline Injection 1mg/1ml PL 12064/0058 

Adrenaline Injection 1mg/10ml PL 12064/0006

Amiodarone Injection 30mg/1ml, 10ml PL 12064/0047

Atropine Sulphate Injection 1mg/5ml PL 12064/0035

Atropine Sulphate Injection 3mg/10ml PL 12064/0057

Atropine Sulphate Injection 600mcg PL 12064/0040

Calcium Chloride Intravenous Infusion BP 10% w/v PL 12064/0020

Ephedrine HCL Injection 30mg/10ml PL 12064/0043

Naloxone Injection 1mg/1ml PL 12064/0060

Suxamethonium Injection 50mg/1ml PL 12064/0065

Further to the Class 4 Drug Alert, EL (11)/A/27, issued on Friday 11th November 2011, Aurum Pharmaceuticals Limited (trading as Martindale Pharma) has informed us that their ongoing root cause investigation has identified a second single ‘rogue’ box within a batch of a different product. As in the previous case, the screen printing of the name of the product on the centre of the longest panel of the yellow plastic box is incorrect but the coloured product identification / tamper evident label on the end of the plastic box is correct and the syringe inside is labelled correctly. Please note, this batch of product has not been released to the market. No further reports from the market have been received to date following the issue of EL (11)A/27.

Since similar findings cannot be ruled out for other batches of Aurum pre-filled syringe products, recipients are asked to inspect their stocks of these products packed in yellow plastic printed boxes as a precautionary measure. Both the screen printed box and the end coloured product identification label will need to be checked on each pack to verify that they are the same. It is not necessary to open the boxes as the contents will be as described on the coloured product identification end label.

Given the critical nature of the products, the range is not being recalled in order to avoid potential stock shortages. We understand that colour differentiated boxes are being introduced for these products. In the meantime, any batches in yellow boxes which are released to the market will be subjected to 100% inspection.

Please see attached PDF for further details