Hospira, a Pfizer company, has issued a worldwide recall of one lot of the opioid painkiller Hydromorphone injection and four lots of the blood pressure medication Levophed injectable because the products were manufactured with a damaged sterilizing filter for nitrogen, which may have compromised the sterility of the drugs.
If these medications are unsterile and administered to patients, adverse events could result ranging from fever, chills, and malaise to severe adverse evens such as septicemia, bacterial meningitides and wound infection. To date, Hospira has not received any reports of adverse events related to this recall.
Hydromorphone Hydrochloride injection is used for the relief of moderate to severe pain. Levophed (norepinephrine bitartrate injection) is used for blood pressure control in certain acute hypotensive states. Affected lots were distributed nationwide to wholesalers and hospitals in the U.S., as well as Puerto Rico, Singapore, and Taiwan, from May 2017 to July 2017. Hospira has initiated an investigation to determine the root cause and begun corrective and preventative measures.
The recall comes just a day after the drug company issued a recall of one lot of injectable Vancomycin Hydrochloride because glass particles were seen floating in a vial. Vancomycin Hydrochloride is used to treat serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci, as well as staphylococcal endocarditis, septicemia, bone infections, lower respiratory tract infections, and skin and skin-structure infections.
Anyone who has been treated with these recalled products should file a report with the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
FDA Recall Notice