Epinephrine Injection Recall Due to Particulate Matter and Sterility Issues

American Regent, Inc. has announced a voluntary nationwide recall of three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multi-dose vials. This recall is due to the presence of particulate matter and a lack of assurance of sterility, which could pose serious health risks.

Affected Products:

• Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multi-dose vials
• Lot Numbers: 25128L1C0, 25280L1C0, 26108L1C0
• Distributed nationwide in the United States

Reason for Recall:

The recall was initiated after customer complaints of leaking and cracked vials, which could compromise sterility. The investigation found particulate matter, including Nylon, Cellulosic, Acrylic, Polyethylene, and Glass. Intravenous administration of affected products may lead to serious health issues, such as blockage and clotting in blood vessels, pulmonary embolism, and potential organ damage.

Consumer Guidance:

Consumers and healthcare facilities should stop using the recalled product immediately and return it to the place of purchase or discard it. Patients using this product should consult their healthcare provider. For questions or concerns, contact American Regent, Inc. at 1-800-645-1706.

Health Risks:

While no adverse events have been reported, the presence of particulate matter can cause significant health risks, including local vein irritation and allergic reactions. Cracked vials may lead to contamination and serious patient risks.

This recall is conducted with the knowledge of the U.S. Food and Drug Administration (FDA). American Regent, Inc. is committed to patient safety and is taking this action to protect public health.