Hospira is recalling one lot of injectable dextrose after what appears to be mold was found in a leaky container, a problem that could contaminate the product and lead to a potentially deadly blood infection, the FDA says.
Hospira ($HSP) this year has had a series of product recalls tied to manufacturing issues. In this case, the voluntary recall stems from a single report and the company hasn't been notified of any adverse event reports. There were no quality issues with retention samples for the lot and the recall is just a precaution.
The company is recalling a single lot of Hospira's Lactated Ringer's and 5% Dextrose Injection, 1000 ml, flexible containers. A leak was found in the primary container "between the cobra cap and fill-tube seal," the announcement says. When a primary container within an overwrap has a leak, there is a chance the fluid will be contaminated from the unsterile overwrap and can get back into the primary container. If that happens and a patient is injected with contaminated solution, there is a chance for blood infections that could lead to septic shock, the warning explains.
In August, the company recalled some of its Carpujects of hydromorphone after a user discovered one that had been overfilled. The month before that it recalled 19 lots of a variety of drugs in the U.S., as well as some internationally, after glass particles were found in some vials--a problem it laid off on its glass supplier. The company has spent most of this year upgrading plants in Austin, TX, and Clayton and Rocky Mount, NC, trying to get on top of the manufacturing issues that have plagued it.
- read the safety alert