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 1-917-480-9107.
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.
Source: Herbsland Press
Release