Hospira ($HSP) has initiated not one, but two, more recalls of injected drugs already on the FDA drug shortage list. One is saline solution and is being recalled after a human hair was found in a delivery bag. This is the second time this has happened since the first of the year.
According to an FDA-issued release, the Lake Forest, IL-based company said on Friday that it was recalling one lot of 0.9% sodium chloride injection, USP, 250 mL in its VisIV flex container, after a customer reported particulate in a single unit. Hospira confirmed that the particulate was a human hair free-floating in the solution. The company said the products were distributed nationwide from December 2014 through January 2015.
Hospira has initiated an investigation to determine the root cause and corrective and preventive actions. The injectable drug specialist said the same thing in January when it recalled another lot of saline for essentially the same reason. In that case, the drugmaker found the human hair sealed in the bag at the additive port area.
Hospira also recalled a lot of magnesium sulfate in 5% dextrose injection last week after a customer found a barcode on the primary container of a unit to be for heparin and not for magnesium sulfate. Hospira said the barcode on the overwrap is correct and the product was labeled with the correct printed name on the primary container and overwrap. Given that, the drugmaker said the chance of someone giving the product for the wrong use is unlikely. However, since the product is often used to treat increased blood pressure and edema during pregnancy, there could be a risk to a mother or the fetus, the company said. That lot was distributed from October 2014 to January 2015.
The two recalls mark the third and fourth by Hospira just since the drugmaker announced last month that drug giant Pfizer ($PFE) was acquiring it for $15 billion. Officials with Pfizer have said they are satisfied with the progress that Hospira has made with its ongoing quality issues that have resulted in warning letters for plants in the U.S., Australia and India. Just last week, the drugmaker acknowledged that its plant in Vizag, India, that it had hoped it would open by the end of last year has received 14 more observations from FDA inspectors during a recent reinspection of the facility. The FDA did its initial preapproval inspection at Vizag in March of last year and at that time presented the facility with a Form 483 with 10 observations.