Chiesi USA, Inc. — Class II: CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials,
Chiesi USA, Inc. has initiated a Class II recall for CLEVIPREX (clevidipine) injectable emulsion, 50 mg/100 mL, due to a lack of assurance of sterility. The product was manufactured by Fresenius Kabi in Austria and the recall is currently classified as ongoing.
This affects Chiesi USA, Inc., the contract manufacturer Fresenius Kabi, and healthcare providers or facilities utilizing CLEVIPREX single-use vials (NDC 10122-611-10).
A lack of sterility assurance in an injectable emulsion represents a significant regulatory risk, as it compromises the primary safety requirement for parenteral drugs. While the source does not detail specific contamination, a Class II designation suggests that while the health risk is not immediate or life-threatening, the failure in aseptic processing or container closure integrity requires comprehensive remediation and inventory removal.
QA and supply chain teams should immediately verify if affected NDR 10122-611-10 lots are in inventory. Manufacturing departments should review the root cause of the sterility assurance lapse at the contract manufacturing site to ensure broad process control across similar injectable emulsion lines.
Class II. Reason: Lack of Assurance of Sterility. 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.. Firm: Chiesi USA, Inc. (Cary NC United States). Status: Ongoing.
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