The FDA is recalling an intravenous solution used to control severe hypertension because of potential contamination.
Hospira is voluntarily recalling one lot of Labetalol Hydrochloride Injection because of particulates in the solution. It identified embedded particulate in glass vials as stainless steel and particles in the solution as iron oxide. If the particulates pass through a catheter they might cause injection site reactions, irritate tissue or damage tissue if exposed to strong magnetic fields.
The recalled lot is 100 mg/20 mL (5 mg/mL) 20 mL multidose vial, NDC 0409-2267-20, Lot 36-225-DD, with an expiration date of Dec. 1, 2015. The lot was distributed in February 2014.
Hospitals with the product should discontinue its use. Physicians and patients can report any related adverse events or side effects to the FDA’s MedWatch program.