Pharmakon Pharmaceuticals has voluntarily recalled its morphine sulfate therapy.
+ Technology/Innovation
Jamie Barrand | Feb 19, 2016

Pharmakon recalls morphine sulfate therapy

Noblesville, Indiana-based Pharmakon Pharmaceuticals recently issued a voluntary recall of its morphine-based intravenous pain therapy, due to the product being shown through laboratory testing to be super-potent.

The recalled morphine was manufactured on Feb. 3; it carries an expiration date of March 19, 2016, and comes from lots E52418EV11C and NDC 45183-0322-78. It is believed to have been distributed to two medical facilities: one in Indiana and one in Illinois.

Giving a patient super-potent morphine may result in breathing problems or coma. It could also be fatal. Concerns about the recalled product arose on Feb. 16 when FDA officials received news that three infants who had been treated with morphine sulfate had experienced severe complications.

The U.S. Food and Drug Administration (FDA) put out an alert so health care providers could pull any stock from their shelves. FDA officials have instructed providers to quarantine any product included in the recall.

To learn more or to report adverse effects from drugs that may have been from the recalled lots, visit the FDA's home page.

Pharmakon was the subject of FDA inspections in March and April 2014; a warning letter was issued to the company in May 2015.

Organizations in this story

More News