Chiesi Usa, Inc.: Cleviprex (clevidipine Injectable Emulsion) 50 Mg/100 Ml (0.5 Mg/ml), 10 Single Use Vials
CLEVIPREX Recall Summary Chiesi USA is recalling CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL vials nationwide because the manufacturer cannot guarantee the product is sterile. CLEVIPREX is a prescription injectable medication used to lower blood pressure. The recall affects vials distributed across all U.S. states.
- Recalling firm
- Chiesi USA, Inc.
- 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.
- Reason
- Lack of Assurance of Sterility
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-07-06
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the United States
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/9f449d9c-0d0c-45ac-acff-5531c84f380b