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Posted March 11, 2002

Recall and Warning to Stop Use of Prostate Supplements "PC SPES" and "SPES"

Note: This posting was origially made on February 8, 2002. Additional information was added on March 11, 2002.

On February 8 MedWatch, the FDA Safety Information and Adverse Event Reporting Program, issued the following warning:

Consumers are warned to 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. Laboratory analysis of the products by the California Department of Health Services 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. PC SPES and SPES are respectively marketed "for prostate health" and strengthening the immune system.

BotanicLab, the manufacturer of the products, has voluntarily recalled ALL LOTS of PC SPES. The recall for the SPES product was reported as a Class II recall in the FDA Enforcement Report of March 6, 2002 as follows: (Note: A Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.)

PRODUCT SPES capsules, Herbal Dietary Supplement, Immune System Formula, 30 capsules per bottle, 300 mg each, containing 15 different herbs. Recall # D-196-2.

CODE Lot 5311214 distributed from 8/9/2001 to 1/8/2002; Lot 5431249 distributed from 10/25/2001 to 1/8/2002.

RECALLING FIRM/MANUFACTURER Botanic Lab Brea, CA, by letters on January 28, 2002. Firm initiated recall is ongoing.

REASON Product contains the undeclared prescription drug alprozolam.

VOLUME OF PRODUCT IN COMMERCE Undetermined

DISTRIBUTION Nationwide and internationally.