February 8, 2002Botanic Lab Has Recalled PC SPES and SPES
Sacramento, CA (SafetyAlerts)
BotanicLab, the Brea-based manufacturer of the products, has recalled PC
SPES and SPES nationwide.
Consumers should immediately stop using the dietary supplement herbal
products PC SPES and SPES capsules because they contain undeclared
prescription drug ingredients that could cause serious health effects if not
taken under medical supervision, State Health Director Diana M. Bontá, R.N.,
Dr. P.H., said today. PC SPES and SPES are respectively marketed "for
prostate health" and strengthening the immune system.
"Consumers should stop using these products and immediately seek medical
advice, especially if they currently are using any other prescribed
medication," Bontá said. "Consumers should consult with their health care
providers whenever they take an herbal product or a dietary supplement."
Her warning followed an investigation and laboratory analysis of the
products by the California Department of Health Services' Food and Drug
Branch that found PC SPES contains warfarin and SPES contains alprazolam,
which are available only by prescription and sold either by their generic
names or the trade names, Coumadin and Xanax, respectively. Warfarin is an
anticoagulant or "blood thinner" used to decrease the clotting ability of
the blood, and alprazolam is used to treat anxiety and panic disorders.
Warfarin can cause serious bleeding, according to CDHS experts. This
bleeding can be affected by many other different medicines, including
aspirin and other anti-inflammatory or pain medicines, antibiotics and
antifungals, thyroid drugs, antidepressants and cholesterol-lowering drugs.
Alprazolam exacerbates the effects of alcohol and other central nervous
system depressants. It also may be habit forming.
PC SPES is available in 60-capsule bottles, and SPES is available in 30
capsule bottles, through mail or telephone order, Internet sales and from
distributors, retailers and health care professionals.
PC SPES are clear capsules that contain light brown powder. The label is
light brown with a blue border and the name "BotanicLab PC SPES" on the
front panel. SPES are clear capsules that contain brown powder. The label is
light brown with a brown border and the name "BotanicLab SPES" on the front
Consumers who have unused SPES and PC SPECS capsules should return the
product in its original packaging to PC SPES Recall Program 2900-B Saturn
Street Brea, CA 92821 (1-800-458-5854). CDHS? Food and Drug Branch is
continuing to investigate these products and can be reached at
1-800-495-3232 for more information. The U.S. Food and Drug Administration
is assisting in the investigation and monitoring of the recalls throughout
the United States.