BotanicLab Releases Official Statement About PC SPES; Products Recalled in Canada, Ireland
February 28, 2002
BREA, Calif.--PC SPES, the prostate health product that was voluntarily recalled in early February, is still in the news. The manufacturer, BotanicLab, released an official statement today on the current status of the product, which has been recalled in two other countries.
The initial U.S. recall was issued Feb. 8 when the California Department of Health (CDH) found PC SPES allegedly tested for warfarin, a prescription blood thinner. In addition, DHS found another BotanicLab product, SPES, contained alprazolam, better known as Xanax. The company told HSR the SPES product did contain alprazolam, which the company believed came from one of its suppliers. However, in terms of PC SPES, BotanicLab contends that the material CDH found may have been a phytocoumarin, a compound naturally synthesized in various green plants that may appear like warfarin in laboratory tests.
Internationally, Canada and Ireland have issued a warning and recall, respectively, for PC SPES and SPES. Health Canada (www.hc-sc.gc.ca) has advised all individuals who may have used these products to stop consuming them and consult their health care practitioner; in addition, BotanicLab recalled the products from Canada. According to the Irish Medicines Board (www.imb.ie), it issued its recall based on Health Canada's report.
In today's statement, BotanicLab reported that PC SPES is currently undergoing commercial and academic testing; once the results come in, they will be shared with CDH and the public. The company has also instituted a rigorous quality control process, beginning at the raw material stage. "These exacting controls will ensure our suppliers adhere to the same quality standards we follow throughout the blending, packaging and shipping process," said John Chen, president of BotanicLab (www.botaniclab.com).
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