Herbsland Company Recalls Ancom Anti-Hypertensive Compound Tablets, Ancom

Date of Recall

2003-01-17

Recall Details

Herbsland Company Recalls Ancom Anti-Hypertensive Compound Tablets

New York, NY - January 17, 2003 -- Herbsland Inc. is recalling all 100 tablet bottles of Ancom Anti-Hypertensive Compound Tablets, an unapproved new drug labeled to contain several prescription drug ingredients, including reserpine, diazepam, promethiazine, and hydrochlorothiazide. The sale of a product with this combination of ingredients poses possible serious health risks including sedation, depression, and potentially life-threatening abnormalities of the blood.

This recall includes all lot codes of the product remaining on the market.

Ancom Tablets were sold without prescriptions to consumers through distributors and retail stores located in the New York City metropolitan area, specifically Manhattan, Brooklyn, and Queens. Nationwide sales are also possible as this product was sold via the Internet.

Ancom Tablets are labeled for anti-hypertensive use and are packaged in white plastic bottles of 100 tablets bearing blue and white lettered labeling. Each bottle is sold in an outer cardboard holding carton. Both the carton and immediate container label bear the product name as Ancom tablets, Anti-hypertensive Compound, and display the manufacture's name as Shanghai Pharmaceutical Industry Corp., Shanghai, China. The labeling also bears Chinese markings, which appear to be dual declarations. The holding carton is white with a pink and blue vertical stripe bearing blue and white lettering. The product carton also includes a pre-printed insert labeled with an ingredient statement and directions for use.

No illnesses have been reported to date. Consumers who have used this product and are experiencing any adverse reactions should seek advice from their physician for appropriate evaluation and treatment of their hypertension.

Consumers who purchased Ancom Anti-Hypertensive Compound Tablets are urged to immediately discontinue use of the product and return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-917-480-9170.

This recall is being conducted in cooperation with the U.S. Food and Drug Administration.

Any adverse reactions experienced with the use of this product should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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