Family firm stops producing sterile talc, citing ‘manufacturing issue’




Lymol Medical, a family-run, privately owned company in Woburn, Mass., is the only U.S. supplier of sterile talc powder. Sterile talc is a low-cost medicine is used to treat malignant pleural effusion, a disease affecting about 150,000 Americans.

Lymol, which uses a contract manufacturer, has suspended production of sterile talc because of a manufacturing issue involving a change in a product component, an attorney for the company told the

Wall Street Journal

.

In April 2016, Lymol recalled more than 25,000 canisters of an aerosolized version of sterile talc. The Food and Drug Administration found manufacturing quality problems during several visits to the company between April and June 2016, the

Journal

report said.

Lymol was formerly known as Bryant Corp. In 2007, Bryant pleaded guilty to federal criminal charges including selling sterile talc powder between 1997 and 2007 without FDA marketing approval and without properly sterilizing it, the article said. The company paid more than $4.5 million in fines, the

Journal

report said.

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Medical professionals must use riskier and more expensive alternatives because of the shortage, the report noted. (Source:

Wall Street Journal,

July 3, 2017.)

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