American Regent is recalling three lots of its Epinephrine Injection, USP 30 mg/30 mL multi-dose vials nationwide after customers reported cracked and leaking vials. The company's investigation then found particulate matter identified as nylon, cellulosic material, acrylic, polyethylene, and glass, according to the company's notice posted by the FDA.
The recall, announced Sept. 3, extends to the consumer level, but the product is not the auto-injector that people carry for food or insect allergies. It is a multi-dose vial used by or under the direction of a physician, typically in hospitals, emergency departments, surgical centers, and clinics. American Regent said it has received no reports of adverse events.
