American Regent, Inc.

Rule Changes

Issued voluntary recall; conducting return/replacement program

American Regent, Inc. issued a voluntary nationwide recall of three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multi-dose vials after customer complaints of leaking and cracked vials raised sterility concerns. The company's investigation found particulate matter — nylon, cellulosic, acrylic, polyethylene, and glass — in the product, which can cause blood vessel blockage, pulmonary embolism, organ damage, or death if administered intravenously.

Updated 2 hours ago