April 1, 2001
FDA Recalls Drug Masked as Herbal Supplement
ARCADIA, Calif.--The Food and Drug Administration (FDA) and the California Department of Health Services warned consumers not to take Anso Comfort Capsules, an over-the-counter herbal supplement that has been found to contain a prescription anxiety drug. In an investigation by the California health department, the product, manufactured by Arcadia, Calif.-based NuMeridian, was found to contain the unlabeled ingredient chlordiazepoxide (a potentially habit-forming controlled substance that enhances the effects of nervous system depressants). The product's ingredients were imported from China, but the capsules were manufactured in California. The product was brought to the health department's attention when a San Francisco woman, who had a history of diabetes and high blood pressure, was hospitalized in January with life-threatening low-blood-sugar levels after taking Anso Comfort capsules. In FDA's press release detailing the recall, the agency stated that the woman may have fallen ill due to a drug interaction between chlordiazepoxide and her prescription medicines. FDA also stated that the company's claims--that the product may help with high blood pressure and cholesterol levels--were unsubstantiated; the product's label, while not mentioning the prescription drug, also stated that consumers may reduce or stop prescription medicine consumption due to the benefits of the product. In response to FDA and California's concerns, NuMeridian, which was formerly Top Line Project USA Group Inc., announced it would voluntarily recall the product under FDA guidance. The capsules are available in 60-cap bottles with a yellow label and green writing, UPC #7-63148-58798-6. For additional information, visit www.fda.gov.
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