Class I recall: American Regent, Inc.: Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx O

American Regent, Inc. has issued a Class I recall for Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL multiple-dose vials, NDC 0517-3030-01, due to presence of particulate matter and lack of assurance of sterility. The recall notice specifies particulate matter identified as nylon, cellulosic, acrylic, polyethylene, and glass, along with reports of broken and leaking vials.

Most relevant for: Clinicians who stock or administer this specific lot of multiple-dose epinephrine vials for intravenous, intramuscular, or subcutaneous use, including in obstetric emergency settings.

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