FDAHealthJuly 6, 2026
Chiesi USA, Inc. — CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Aust
⚠️ Lack of Assurance of Sterility
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 6, 2026
Nationwide within the United States
What's affected?
- Product
- CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10.
- Brand
- CLEVIPREX
- Lot code
- 1239521
Additional details
Lot #: 1239521, 1237454, Exp. Date 10/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 44280 vials.
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