Lincare drops ball on drug recall, Rx board charges

Sunday, March 23, 2003

March 24, 2003

KANSAS CITY, Mo. - The Board of Pharmacy issued a restraining order on March 5 against a Lincare’s respiratory drug subsidiary, Med 4 Home, for failing to properly recall contaminated respiratory drugs that the company had compounded, the Kansas City Star reported.

The restraining order, which was enforced through March 21, forced the company to stop compounding the drugs.

Also on March 5, Med 4 Home denied a pharmacy board inspector access to its compounding areas, which violated state law, the Star reported.

The state pharmacy board, which began investigating the pharmacy in January, cannot assess fines.

As many as 19,000 patients nationwide might have received the contaminated drug - an albuterol/ipratropium inhalant. Another compounded inhalant, Budesonide, also may have been contaminated.

A routine state inspection revealed a bacteria contaminant - Burkholderia cepacia - in some of the product, the Star reported.

According to recent research by the Centers for Disease Control, the bacteria is particularly dangerous for patients suffering fromcystic fibrosis, in some cases producing a fast-moving, invasive andfatal infection.

The pharmacy board has not received notice from any patients who became sick because of using the contaminated drugs.

Med 4 Home initially recalled only parts of the batches that it thought had been contaminated, instead of the entire product, the Star reported.