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Published on 3 June 2010

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Dyloject recall amid contamination

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Dyloject – the intravenous form of painkiller diclofenac – has been withdrawn from the UK market due to a Drug Alert Class 2 Medicines Recall, according to procurement leaders.

The company that makes the drug, Therabel Pharma UK, a subsidiary of Therabel Pharma NV, took the action to remove all batches of Dyloject (diclofenac 75mg/2ml) from sale after it discovered “the presence of a white particulate matter in some vials of Dyloject in its supply chain”.

The company has reported the matter to the Defective Medicines Reporting Centre of The Medicines and Healthcare Products Regulatory Agency (MHRA) and said it is co-operating fully with the MHRA. Therabel added that it is working hard to fix the problem and to get Dyloject back on the market as soon as possible.

Despite the swift action to recall the products, Therabel said a review it has carried out “does not appear to indicate any detected patient safety concerns linked to the particulate matter found in some vials”.

Therabel has indicated that it is cooperating fully with the MHRA and is active in an investigation to resolve this matter and to restore the supply of Dyloject to the UK market as soon as possible.

Copyright Press Association 2010

Therabel



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