🕒 Created

American Regent, Inc. Issues Nationwide Recall of Epinephrine Injection Vials Due to Sterility Concerns

American Regent, Inc. has issued a voluntary nationwide recall of three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multi-dose vials. The recall was initiated following customer complaints regarding leaking and cracked vials, which raised concerns about the product's sterility. An investigation by the company revealed the presence of particulate matter, including glass, nylon, cellulosic, acrylic, and polyethylene, within the solution. These injections are commonly used for the emergency treatment of allergic reactions, such as anaphylaxis, and to increase mean arterial blood pressure in adult patients with septic shock. The company warned that intravenous administration of the affected product could lead to serious health consequences, such as blood vessel blockages, clotting, and potential organ damage. The affected products were distributed nationwide in the United States. Patients using the recalled lots should stop using them immediately and contact their healthcare provider. American Regent, Inc. is notifying distributors and customers by letter and is arranging for the return or replacement of all recalled products.

Sources