Drug is voluntarily withdrawn from UK market
Javelin Pharmaceuticals Inc., a Cambridge developer of acute care pain products, said that a licensee of its Dyloject drug has announced that it is withdrawing all batches of Dyloject from the UK market to ensure patient safety.
The licensee, Therabel Pharma UK Limited, "reported that it became aware of the presence of a white particulate matter in some vials of Dyloject in its supply chain," Javelin said in a press release. "These findings were promptly reported to The Defective Medicines Reporting Centre of The Medicines and Healthcare Products Regulatory Agency in accordance with standard procedures."
Therabel added that its review of the situation does not appear to indicate any detected patient safety concerns linked to the particulate matter found in some vials. Javelin said it is providing assistance to Therabel with its investigation.