In an August 30th announcement, the Lake Forest, IL-based company said it is recalling one lot of its parenteral nutritional product Aminosyn II 10%, sulfite-free, 500 mL.
That "foreign particle," Hospira explained, was human hair—a decidedly non-sterile organic addition to an injectable product that requires high levels of sterility. The company said in a statement that it has not received any reports of adverse events associated with the contamination, and that a root cause investigation is underway.
The recall comes just months after Hospira announced that FDA inspectors had found its Irungattukottai, India manufacturing facility to have "significant violations" of current good manufacturing practices, resulting in a Warning Letter being sent to it on May 28, 2013. Read more