The particulate matter was found by a customer in a single unit of Hospira’s 0.9% Sodium Chloride Injection, and was confirmed by the company to be a human hair “sealed in the bag at the additive port area.”
Hospira has issued a voluntary recall of a single lot distributed from September through November 2014 which was made at the firm’s Lake Forest, Illinois facility, according to the US Food and Drug Administration (FDA) safety alert.
The firm has begun an investigation to determine the cause of the contamination and is looking into preventative measures, and the affected lot has not been associated with any adverse events for patients.
"One recall too many"
According to US FDA data, 45 class I recalls were conducted by drug makers in 2014, including both those initiated by the firm involved and those ordered by the agency.
Almost a third of these recalls (14) were related to Hospira drugs - including heparin, Marcaine (bupivacaine HCl injection), propofol, and lidocaine – twice as many as the next most recalled fir, Baxter. A further four medical devices made by the firm were also recalled last year.
“We recognize that one recall is one recall too many,” spokesperson Lindsey Negaard told in-Pharmatechnologist.com. “Hospira remains committed to achieving the highest standards of product and manufacturing quality for our customers and patients.”
Since 2012, Hospira has issued 28 drug and 11 medical device recalls, with this Sodium Chloride Injection recall becoming the fortieth, and after the recall of ten lots of Mitoxanthrone – an anthracenedione antineoplastic agent used to treat cancers - the second within a month.
Hospira has had its fair share of problems with quality. The Rocky Mount, North Carolina manufacturing plant has been under an FDA warning letter since 2010, though the firm is confident of its imminent return to health following a huge remediation effort. The Clayton, Illinois plant – now earmarked for closure - too was hit by a warning letter the same year.
Lake Forest’s device plant and a finished pharmaceutical facility in Irungattukottai (IKKT), India, both were hit with FDA warning letters in 2013, while problems have been found following inspections at an API plant in Boulder, Colorado, and anew 1.1m2 injectables plant in Vizag, India, which received a 483 with 10 observations last May.