Bioniche Reports Positive News from BetacTM Product Recall Investigation
-- Betac does not present significant risk to humans; potency and pH of product not affected --
BELLEVILLE ON, July 12, 2005 - Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that an investigation into its injectable ascorbic acid product, BetacTM, 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.
“We’re pleased with the positive results of this investigation,” said Graeme McRae, President & CEO of Bioniche Life Sciences Inc. “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.”
Betac is produced at Bioniche Pharma Group Limited’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.
The precipitate issue affected Betac only. The Food and Drug Administration (FDA) and Health Canada have been involved with Bioniche in both the voluntary recall and in the post-recall investigation.