Mass. pharmacy recalling some compounded products

Posted: Published on March 26th, 2013

This post was added by Dr P. Richardson

BOSTON (AP) -- A Massachusetts pharmacy issued a voluntary recall Monday of some of its sterile compounding products after "foreign matter" was found in drug vials during an unannounced inspection by state and federal officials.

Pallimed Solutions Inc., of Woburn, was also ordered by the state board of pharmacy to stop all sterile compounding activities until further notice.

Most of the recalled items were used to prepare erectile dysfunction treatments for patients who have difficulty taking drugs orally. The company said fewer than 800 patients were involved.

The company described the recall as a precautionary measure and said it had received no reports of any illnesses or injuries. It also said it would continue with nonsterile compounding.

The Massachusetts Department of Public Health said it requested the recall after a joint inspection on Friday by the state pharmacy board and the U.S. Food and Drug Administration.

"The cease and desist was issued after foreign matter was observed in vials of injectable drugs," the Department of Public Health said in a statement.

Pallimed also was ordered to place all its compounded sterile products into quarantine while the investigation continued.

The company said there was no indication the products were tainted or unsafe. The state also said there were no reports of any patient harm.

A message was left with the FDA.

Massachusetts stepped up unannounced inspections of compounding pharmacies after a deadly fungal meningitis outbreak last year was linked to an injectable steroid produced at another Massachusetts company, New England Compounding Center.

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Mass. pharmacy recalling some compounded products

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