Import of Laxachem Products Halted by FDA due to Inspection Issues

Laxachem manufactures active pharmaceutical ingredients (API) for repackers, labelers, and wholesale drug distributors, some of which do business with manufacturing facilities in the United States. One of the drugs Laxachem manufactures is Docusate Sodium USP, a stool softener that is often prescribed by doctors for the treatment of bowel movement problems.

On August 11, 2016, the U.S. Food and Drug Administration (FDA) placed Laxachem Organics Pvt. Ltd., Ahmednagar, from Maharashtra, India on import alert after the company had refused FDA investigators access to their facility for inspection. This lack of cooperation led the agency to halt all Laxachem pharmaceutical products from entering the United States legally.

A voluntary nationwide recall in July 2016 was announced by the FDA, of oral liquid docusate sodium manufactured by PharmaTech, Davie, Florida, as well as a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan. The FDA confirmed the product had been contaminated with Burkholderia cepacia, a bacteria associated with an outbreak in five states.

Companies that received API from Laxachem Organics should not distribute those products to customers, according to the FDA website. Under the Federal Food, Drug and Cosmetic Act (FD&C Act), drugs, including APIs made at a facility that denies FDA inspection, are considered adulterated.

The risk of possible Burkholderia cepacia contamination caused the FDA to alert health care professionals and consumers of a voluntary recall involving PharmaTech products. The FDA received adverse event reports related to oral liquid docusate sodium, but was not aware of any similar reports related to additional recalled products.

Until the FDA is given the ability to fully inspect the manufacturer’s facility and prove its products meet U.S. standards, Laxachem will remain on import alert.

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