FDAnews
www.fdanews.com/articles/165620-hospira-recalls-marcaine

Hospira Recalls Marcaine

July 4, 2014

Injectables maker Hospira is facing yet another recall after a customer found particulates embedded in a vial of 0.5 percent Marcaine painkiller.

The affected lot was distributed to wholesalers, distributors, hospitals and clinics around the country between November 2013 and March 2014. Hospira says that the particulates likely came from a supplier’s glass defect and that it is working with the company on corrective and preventive actions.

To date, no adverse events have been reported, though the company recommends that customers quarantine potentially affected vials.

Hospira is no stranger to recalls. In May, the company recalled its heart disease drug dobutamine over discoloration in a single vial. A month before that, the drugmaker was forced to recall one lot of Marcaine (bupivacaine HCl injection, USP) and seven lots of propofol.

In November 2013, the company landed a Form 483 for glass particles found in sterile lyophilized drugs during a summer inspection of the company’s McPherson, Kan., manufacturing plant. The month before that, the drugmaker was forced to recall one lot of 1 percent lidocaine HCl injection.

Don’t be forced to recall contaminated products. Take a look at your manufacturing practices and order Manufacturing Sterile Products to Meet EU and FDA Guidelines today!