Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial
Product details
- Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial
Company announcement
American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials.
The recall, announced on September 3, 2026, is due to customer complaints of leaking and cracked vials, leading to a lack of assurance of sterility.
An investigation also found particulate matter, including Nylon, Cellulosic, Acrylic, Polyethylene, and Glass, in the product.
To date, no adverse events have been reported in connection with this recall.
Risk:
Intravenous administration of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) containing particulate matter may lead to serious adverse health consequences. 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. Additionally, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, and allergic reactions. Additionally, cracked vials can compromise the integrity of the container resulting in loss of sterility and potential contamination which can pose a serious risk for patients.
Impacted states: Nationwide
Products:
- Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial, Lot 25128L1C0 (UPC code(s): 0517303001)
- Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial, Lot 25280L1C0 (UPC code(s): 0517303001)
- Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial, Lot 26108L1C0 (UPC code(s): 0517303001)
Contact
For more information, call 1-800-645-1706.