Drugmaker American Regent on Thursday launched a voluntary recall of epinephrine injection due to leaking and cracked vials.
The company said it is notifying distributors and consumers directly to arrange for returns and replacements of its multidose vials USP 30 mg/ 30 mL, 1 mg/mL.
"Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility," American Regent said in a statement distributed by the Food and Drug Administration.
Epinephrine, which is applied via an autoinjector, is used to treat allergic reactions and increase arterial blood pressure in adults with hypotension.
"The firm's investigation also revealed the presence of particulate matter identified as Nylon, Cellulosic, Acrylic, Polyethylene and Glass," the pharmaceutical company said.
Particulate matter are tiny particles found in a substance that should otherwise be clear. If injected, such particles could pose health risks.
"Particulate matter can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs (pulmonary embolism) and cause permanent organ damage or death," the statement posted by the FDA said.
"Additionally, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, and allergic reactions."
American Regent said it has not received reports of adverse events due to this recall.
The company can be contacted at 1-800-645-1706.
