U.S. Food and Drug Administration

 FDA News Release,  Feb 20, 2001

Anso Comfort Capsules Recalled by Distributor: Ingredient Poses Danger if not Medically Supervised

SACRAMENTO - Feb. 13, 2001 - Consumers should immediately stop using the herbal product Anso Comfort capsules because it contains the undeclared prescription drug chlordiazepoxide, State Health Director Diana Bontá, R.N., Dr. P.H., warned today. Chlordiazepoxide, available by prescription either by its generic name or the trade name Librium, is used for anxiety and as a sedative and can be dangerous if not taken under medical supervision.

The Arcadia-based distributor, NuMeridian, formerly known as Top Line Project USA Group Inc., is voluntarily recalling the product nationwide. An investigation by the California Department of Health Services’ (DHS) Food and Drug Branch and Food and Drug Laboratory found that the product contains chlordiazepoxide. The ingredients for the product were imported from China and the capsules manufactured in California.

A San Francisco woman was hospitalized in January with life threatening low blood sugar after consuming Anso Comfort capsules. The woman has a history of diabetes and high blood pressure. The hospitalization may have been due to a drug interaction of the chlordiazepoxide and the prescribed medications for her other medical conditions. She is expected to fully recover. Her physician referred the case to DHS for investigation by the California Poison Control System.

Bontá advised consumers to stop using Anso Comfort capsules and seek medical advice, especially if they currently are using prescribed medication. Chlordiazepoxide, a controlled substance, adds to the effects of alcohol and other central nervous system depressants. It also may be habit forming.

Advertising for the product claims the capsules are useful for the treatment of a wide variety of illnesses, including high blood pressure and high cholesterol, in addition to claims of being a natural herbal dietary supplement. The advertising also claims that the product only contains Chinese herbal ingredients and that consumers may reduce or stop their need for prescribed medicines. No clear medical evidence supports any of these claims.

“Consumers should not reduce or stop using their prescribed medicines without talking to their health care providers,” Bontá emphasized. “It is also crucial that consumers consult with their health care providers when they are taking an herbal product or dietary supplement.”

Anso Comfort capsules were available by mail or telephone order from the distributor. The capsules, available in 60-capsule bottles, are clear with dark green powder inside. The label is yellow with green English printing and a picture of a plant. The UPC number is 7-63148-58798-6.

The U.S. Food and Drug Administration will assist in the follow-up investigation to monitor the recall throughout the United States. Consumers who have any Anso Comfort should return the product to NuMeridian, located at 630 W. Duarte Road, No. 204, Arcadia CA 91007, or dispose of it safely to prevent exposure to children and pets.

The FDA posts press releases and other notices of recalls from the firms involved as a service to consumers, the media, and other interested parties. The FDA does not endorse either the product or the company.

The text in this article was prepared by the FDA Office of Public Affairs.