HIGHRegulatoryTier 1
American Regent, Inc. Issues Voluntary Nationwide Recall of Three Lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) Due to the Presence of Particulate Matter and Lack of Assurance of Sterility
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
Dental practices that stock epinephrine for emergency kits or local anesthetic reversal now face an immediate supply interruption and sterility risk from three recalled lots of American Regent Epinephrine 30 mg/30 mL vials.
Key points
- Recall covers three specific lots of 30 mg/30 mL multi-dose vials; affected product was distributed nationwide.
- Reason for recall: particulate matter plus cracked/leaking vials that compromise sterility.
- Epinephrine is used in dental offices for anaphylaxis protocols and as reversal agent for local-anesthetic toxicity.
- Clinics should immediately quarantine inventory, verify lot numbers, and contact American Regent for replacement stock or alternative suppliers.
Who should care
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Read the original on FDA Recalls
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