Quality & complianceOfficial

Class I drug recall: Epinephrine Injection (American Regent, Inc.)

🇺🇸 FDA enforcement report · Wed 16 Sep 2026

Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials. Recall D-0865-2026; status Ongoing; distribution: Nationwide within the U.S.A.

Official source: FDA enforcement report ↗

Brief written by VigiEye from the company's press release. Claims are the company's own. AI-assisted; check the source before acting.

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