Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted May 3, 2002
More Information on Recall of PC-SPES - Prostate Supplement
PRODUCT PC SPES, Prostate Formula, Herbal Dietary Supplement, 60 capsules, 320 mg each, over-the-counter sales. Recall # D-198-2. Indicated for "prostate health" claim. An herbal dietary supplement containing Chinese herbs (Reishi, Baikal Skullcap, Rabdosia, Dyer's Woad, Mum, Saw Palmetto, San-Qi Ginseng, Licorice).
CODE All lots and all codes.
RECALLING FIRM/MANUFACTURER International Medical Research, dba Botanic Labs Inc., Brea, CA, by letter dated February 8, 2002. State initiated recall is ongoing.
REASON The product contains the undeclared prescription drug; Warfarin
VOLUME OF PRODUCT IN COMMERCE Unknown.
DISTRIBUTION Nationwide and Internationally.
In a related development, Reuters Health reported on April 9 that researchers presenting at the 93rd Annual Meeting of the American Association for Cancer Research confirmed the presence of the blood thinner warfarin and the anti-inflammatory drug indomethacin in samples of PC-SPES. They also reported finding the potent estrogenic drug diethylstilbesterol (DES). DES is known as the drug given to pregnant women that resulted in reproductive abnormalities in their daughters. It had also been used as treatment for prostate cancer but was stopped because it was associated with clot-formation in deep veins.