American Regent recalled Epinephrine Injection USP 30 mg/30 mL multi-dose vials due to potential particulate matter and loss of sterility assurance. Users of affected vials face serious risk if the contamination is present, as injection of particles or non-sterile product could cause infection or other harm.
Class II (our estimate) — Eating this product may cause temporary or medically reversible health problems; serious harm is unlikely.
The agency has not published a classification for this recall yet. FDA enforcement data runs about a month behind the initial announcement, so we estimate severity from the stated hazard and replace it with the official class when it arrives.
Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial
Potential Foreign Material — Presence of particulate matter and lack of sterility assurance
Image published by the U.S. Food and Drug Administration.
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Do not rely on this site to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Always check the original FDA or USDA notice, linked on every recall page.