The recalls – adding to the total of more than 40 since 2012 – include a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 250 mL VisIV flex container, a voluntary recall of one lot of Magnesium Sulfate, as well as two infusion pumps called Plum A+ and A+3.
The troubles come more than a month after Pfizer acquired Hospira for $17bn. Hospira declined to comment on how these recalls will impact the integration of Hospira and Pfizer.
The recall of the injection is to the user level and due to one confirmed customer report of particulate in a single unit, which was confirmed by Hospira as human hair free-floating within the solution. To date, Hospira has not received reports of any adverse events associated with this issue for this lot, which was distributed nationwide from December 2014 through January 2015. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.
As part of the recall, Hospira laid out a number of patient risks from the contamination, which it says have a low chance of occurring “as there is no evidence indicating that IV injection of inert particles results in harm to patients when only a small amount over a limited period of time is administered.”
“Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately…Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States,” the company said.
The company also announced a voluntary recall of one lot of Magnesium Sulfate in 5% Dextrose, Inj., USP, 10 mg/mL to the user level due to confirmed customer reports of an incorrect barcode on the primary bag labeling.
The Plum A+ and A+3 infusion pumps were also recalled by the Lake Forest, IL-based company due to an alarm-related issue that should sound when a therapy is interrupted.
“Some of the alarms may fail to sound in situations that should trigger it. It is possible for a long delay before a health care professional becomes aware of the need to restore therapy,” the company said
No injuries, illnesses, or deaths associated with this defect have been reported, though there is a risk of injury resulting from this prolonged interruption in therapy and there’s also a possibility of serious patient injury or death.
The recalls also come as Hospira announced late last month that the launch of its Vizag manufacturing facility will be pushed back again due to a Form 483, according to an SEC filing.
The Form 483 contains 14 observations relating to an inspection of the site in Visakhapatnam, India from February 16 through February 25.
The drugmaker did not provide any specifics about the observations but that it "intends to respond fully and in a timely manner…[and] there can be no assurance that the FDA will be satisfied with the Company’s response. The company must obtain the approval of the FDA in order to commercialize products produced at the Vizag facility.”
A preapproval inspection at Vizag in March 2014 by the FDA also resulted in a Form 483 with 10 observations. CEO F. Michael Ball told analysts previously that he hoped the facility could open by the end of 2014.