Therabel Pharma UK, a subsidiary of Therabel Pharma N.V. has publicly announced that it is withdrawing all batches of Dyloject (diclofenac 75mg/2ml) from the UK market with a Drug Alert Class 2 Medicines Recall.
Therabel reported that it became: "aware of the presence of a white particulate matter in some vials of Dyloject in its supply chain".
These findings were reported to The Defective Medicines Reporting Centre (DMRC) of The Medicines and Healthcare Products Regulatory Agency (MHRA) in accordance with standard procedures.
Therabel further reported that its review of pharmacovigilance information "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. Javelin is providing assistance to Therabel with its investigation.
Dyloject has been marketed in the UK since December of 2007.
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