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Recall -- Firm Press ReleaseFDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. Bioniche Issues Recall of BetacTMContact: FOR IMMEDIATE RELEASE -- Belleville, ON -- June 17, 2005 -- Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that the Canadian arm of its Pharma Division (Bioniche Pharma Canada Limited) is initiating a Class 1 recall of BetacTM, (NDC 62086-139-50/DIN 02245625), an injectable ascorbic acid product that is produced at the Bioniche Pharma Group Limited’s sterile injectable manufacturing facility in Galway, Ireland. Approximately one-third of the product released to the market has been found to contain visible particulate matter (microbial in origin) which could potentially result in serious adverse health reactions. No such reactions have been reported to date, however, in the event of a reaction, health care professionals are encouraged to contact the Company or their regional regulatory authority: Contact information:U.S. health care professionals Call Bioniche Life Sciences at 1-888-258-4199 or FDA’s MedWatch program at 1-800-FDA-1088 Contact the FDA via the MedWatch website at www.fda.gov/medwatch, or by mail (using postage-paid form) to MedWatch, HFD-410, 5600 Fishers Lane, Rockville, MD 20857-9787. Canadian health care professionals Call Bioniche Life Sciences at 1-888-258-4199 or the Adverse Drug Reaction Centre of Health Canada at 1-866-234-2345. Bioniche Pharma voluntarily recalled all lots of the product after learning about the issue. The product is sold to pharmacies and clinics, either directly or through distributors. All recipients have been notified by phone and fax. The Food and Drug Administration (FDA) and Health Canada were immediately apprised of this action, and Bioniche is working with these agencies to ensure that the recall is handled efficiently. Meanwhile, the Company’s Quality Control staff and management have isolated all potentially affected product and are investigating the cause of the problem. Immediate corrective action will follow. |
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