United StatesCLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 single‑use vials, NDC 10122-611-10, manufactured for Chiesi USA by Fresenius Kabi (Lot #1239521 and #1237454, Exp. 10/2027) is being recalled. The recall was initiated due to lack of assurance of sterility; 44,280 vials were distributed nationwide in the United States.
What's being recalled
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.
Recalling firm: Chiesi USA, Inc., Cary, NC, United States.
How to identify it
Lot #: 1239521, 1237454, Exp. Date 10/2027
The hazard
Lack of Assurance of Sterility
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the United States
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)