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Recalls for October, 2000


© Adelle Vancil Tilton

This month it seems that the pharmaceutical industry has been behaving itself, since there are only four new recalls that have been issued, however there is a major recall possibly in the works that will have a major impact on healthcare throughout the United States.

On October 25, Congressman Dan Burton, (R) Indiana, wrote Secretary of Health and Human Services Donna Shalala asking that the Food and Drug Administration issue a recall on all vaccines which contain Thimerosal. In his letter, Burton, the Chairman of the House Committee on Government Reform is quoted as saying, "We all know and accept that mercury is a neurotoxin, and yet the FDA has failed to recall the 50 vaccines that contain Thimerosal...On their own website, the FDA states, ‘lead, cadmium, and mercury are examples of elements that are toxic when present at relatively low levels’. Our children are the future of this country. As a Government we have a responsibility to do everything within our power to protect them from harm, including ensuring that vaccines are safe and effective. Every day that mercury-containing vaccines remain on the market is another day HHS is putting 8,000 children at risk. Given that Thimerosal-free vaccines are available, and the known risk of mercury toxicity, to leave Thimerosal-containing vaccines on the market is unconscionable."

If Burton's request is granted, it would change the course of Public Health in the United States. Since immunizations are a keystone of the Health and Human Services programs throughout the country, we could see major changes in the way that this program is administered, in the vaccination schedules that currently are in use, and in the way that healthcare decisions are made by the Federal and State governments.

IIllumine™ 30 Minute in-Office Tooth Whitener The FDA announced the recall of certain lots of IIllumine™ 30 Minute in-Office Tooth Whitener because of a defective coupling valve which can result in the forceful ejection of the contents. Manufactured by Dentsply Preventive Care of York, Pennsylvania, this product is used by dental offices throughout the United States, Mexico, Germany, Argentina, Brazil, Australia, Japan and Hong Kong. Included in the recall are Lot Numbers 1229, 1234, 1240, 1241, 1251, 1253, 1254, 1255, 1259, 1259A, 1262, and 1280.

Iopamidol-300 American Pharmaceutical Partners Inc. has recalled certain lots of its Iopamidol-300 because of a lack of efficacy. The drug, is used for angiography throughout the cardiovascular system and intravenous adult and pediatric contrast enhancement of computed tomographic head and body imaging. Included in the recall are lot numbers Lot Numbers 100119 EXP 02/02 and 100393 with expiration dates of 05/02. The product is distributed in California and Virginia, and it is estimated that 10% of the product remained on the market at the time of the recall.

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