D-0689-2026 Class II Ongoing
FDA drug recall D-0689-2026 was initiated by Chiesi USA, Inc. on July 6, 2026 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 44280 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- July 22, 2026
- Initiation Date
- July 6, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44280 vials
Product Description
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 for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 1239521, 1237454, Exp. Date 10/2027