It’s a case of twos: Two pharmaceuticals manufactured in two North Carolina plants have been recalled for a second time in six months due to contamination after equipment failure.
The products (both by Hospira, Inc.) are a numbing agent called Propofol, and an intravenous nutritional product called Liposyn–both sold only to doctors and hospitals. The drugs, which are manufactured in Rocky Mount and Clayton, NC, were recalled on November, 6, 2009… and again on April 16, 2010.
The problem in both recalls is the same: Stainless steel particulates made their way into the pharmaceuticals during the manufacturing process. According to a Hospira press release from the first recall (made available by the FDA):
“Since these particulate contaminants do not dissolve in blood they could potentially act as emboli and impede blood flow. Particulates may also cause mechanical damage to the body and may escalate damage through the Systemic Inflammatory Response Syndrome (SIRS). Restriction in blood supply to tissues could lead to stroke, respiratory failure, kidney failure, liver failure, heart attack and/or death.” [emphasis added]
After two inspections by the U.S. Food & Drug Administration (FDA) in early 2010, the FDA issued a warning letter to Hospira citing several inspection violations, with the conclusion that the manufacturing problems continued. This prompted the April 16, 2010, national recall.
According to a report on Raleigh’s WRAL website, Hospira officials said the company is still manufacturing the drugs at the Clayton facility and are waiting for approval from the Food and Drug Administration before further shipments.
If it’s true that they are continuing to manufacture the recalled products before receiving FDA approval, that’s pretty frightening. And potentially dangerous.
Although there have not yet been any reports of patients being harmed by the recalled products, that doesn’t mean that we’re in the clear. If you were a patient and received either of these products while in a hospital or under a doctor’s care, you probably have a lot of questions. If you are worried that you may have suffered harm after receiving Propofol or Liposyn in the past 8 months or so, call HensonFuerst Attorneys.
If you have questions, HensonFuerst has answers.