Firm's Herbal Products Said to Contain Prescription Drugs
The recall involves all lots of Spes and PC Spes, products of BotanicLab of Brea, Calif. According to the state's health department, BotanicLabs "immune system enhancing" herbal remedy, Spes, contains alprazolam, a Schedule IV controlled substance legally available only by prescription. The health department also determined that PC Spes, which is marketed as a "prostate health" remedy, contains warfarin, a prescription drug derived from coumarin.
BotanicLab announced that it had instituted a voluntary recall of Spes on Jan. 28. The company issued an "urgent dietary supplement recall" notice for PC Spes on Feb. 8, one day after the California health department announced its laboratory findings. The Food and Drug Administrations MedWatch system issued a notice about both recalls on Feb. 8.
In the Spes recall notice, BotanicLab confirmed the alprazolam contamination and speculated that it occurred in China, the source of the raw materials for the product. But the company disputed the warfarin contamination, saying that the material found in PC Spes may be a naturally occurring "phytocoumarin," not a synthetic additive.
PC Spes's usefulness in the treatment of prostate cancer is under investigation. However, a University of CaliforniaSan Francisco study comparing PC Spes with diethylsilbestrol in patients with prostate cancer was halted unexpectedly in early January.
Consumers can return unused PC Spes and Spes capsules in their original packaging to PC Spes Recall Program (or Spes Recall Program), 2900-B Saturn Street, Brea, CA 92821, for a full refund.
|Update, 24 May 2002The Wall Street Journal reported May 21 that BotanicLab said it will cease operations June 1. According to the newspaper, the companys chief operating officer said recently received batches of the raw herbs, obtained from China, did not meet standards for purity. Newsday had reported May 12 that BotanicLab spokespersons said the company expected to have PC Spes available in June after overhauling quality-control procedures and hiring a London-based laboratory to test products for contaminants.|