March 1, 2001
FDA Recalls Herbal Supplement Containing "ControlledSubstance"
ARCADIA, Calif.--The Food and Drug Administration (FDA) and the CaliforniaDepartment of Health Services warned consumers not to take Anso ComfortCapsules, an over-the-counter herbal supplement that has been found to contain aprescription anxiety drug. In an investigation by the California healthdepartment, the product, manufactured by Arcadia, Calif.-based NuMeridian, wasfound to contain the unlabeled ingredient chlordiazepoxide (a potentiallyhabit-forming controlled substance that enhances the effects of nervous systemdepressants). The product's ingredients were imported from China, but thecapsules were manufactured in California.The product was brought to the health department's attention when a SanFrancisco woman, with a history of diabetes and high blood pressure, washospitalized in January with life-threatening low-blood-sugar levels aftertaking Anso Comfort capsules. In FDA's press release detailing the recall, theagency stated that the woman may have fallen ill due to a drug interactionbetween chlordiazepoxide and her prescription medicines.FDA also stated that the company's claims--that the product may help withhigh blood pressure and cholesterol levels--were unsubstantiated; the product'slabel, while not mentioning the prescription drug, also stated that consumersmay reduce or stop prescription medicine consumption due to the benefits of theproduct.In response to FDA and California's concerns, NuMeridian, which was formerlyTop Line Project USA Group Inc., announced it would voluntarily recall theproduct under FDA guidance. The capsules are available in 60-cap bottles with ayellow label and green writing, UPC #7-63148-58798-6. For additionalinformation, visit www.fda.gov.
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