American Regent, Inc. — Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY
Official product recall notices and clearly labeled enforcement reference records.
Reference record — not a live warning · enforcement-reference · official-source
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.
- Posted by source
- Source last updated
- Current version retrieved
- Provider
- FDA — drug enforcement reference
- Location
- Shirley, NY, US
- hazard
- 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.
- notice
- Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
- product
- Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-3030-01
- distribution
- Nationwide within the U.S.A
- manufacturer
- American Regent, Inc.
- recall number
- D-0865-2026
- source status
- Ongoing
- classification
- Class I
- freshness minutes
- 180
Source use policy · openFDA reference data; not a real-time public alert service
Update history (1 recent revisions)
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