Cambridge, UK (21 May 2010).
Therabel Pharma UK Limited today confirmed that it is withdrawing all batches of Dyloject (diclofenac 75mg/2ml) from the UK market with a Drug Alert Class 2 Medicines Recall (for action within 48 hours).
Earlier this month, Therabel Pharma UK Limited became aware of the presence of a white particulate matter in some vials of Dyloject. 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.
A review of Pharmacovigilance information, carried out by Therabel Pharma UK Limited, does not appear to indicate any detected patient safety concerns and the affected batches have been in use since 2008.
Therabel Pharma UK Limited is committed to ensuring patient safety. As a precaution, and in agreement with the DMRC, the company is recalling all batches of Dyloject stock from the UK market and a Drug Alert Class 2 Medicines Recall (for action within 48 hours) is being issued by the MHRA’s DMRC.
Therabel Pharma UK Limited is co-operating 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.
Stock should be returned via the original wholesaler for credit.
For stock return and general enquiries please call Therabel Pharma UK Ltd on 01223 257759.
For medical information enquiries please call Therabel Pharma UK Ltd Medical Information on 0800 066 5446.
For media inquiries contact Roseann Ward, Resolute Communications Limited.
Tel: + 44 (0) 20 7397 7495, Mobile: + 44 (0) 7932 798151 .