Bioniche says recalled product is safe

The investigation into Betac has shown that the product is free of microbial contamination. Betac was the subject of a voluntary Class 1 recall last month after one-third of the product released to the market was found to contain a small amount of visible particulate matter.

The particulates have now been identified as a calcium oxalate precipitate, which does not present a significant risk to human health. In addition, it was determined that the potency and pH of the product have not been affected by the presence of the precipitate.

Betac is produced at Bioniche Pharma Group’s sterile injectable manufacturing facility in Galway, Ireland. The product is sold to pharmacies and clinics, either directly or through distributors. All recipients were notified of the voluntary recall.

Graeme McRae, president & CEO of Bioniche Life said: “Our quality control staff in Ireland and Canada handled the situation efficiently and effectively, voluntarily recalling the product and taking a very cautious approach until more information was known about the nature of the particulate matter.”