Cleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
Chiesi USA, Inc. is recalling Cleviprex (clevidipine) injectable emulsion due to lack of assurance of sterility. The affected product is distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall for a sterility defect in an intravenous drug product. Lack of sterility assurance in injectable medications poses a potential for serious health consequences including infection and sepsis, meeting the Severe threshold even without reported illnesses.
Plain-English summary
Chiesi USA, Inc. is recalling Cleviprex (clevidipine) injectable emulsion 50 mg/100 mL (0.5 mg/mL) because the manufacturer cannot assure the product's sterility.
The affected product is Cleviprex Lot #1239521 and Lot #1237454 with expiration date 10/2027. This is a prescription-only intravenous medication manufactured for Chiesi USA, Inc. by Fresenius Kabi in Graz, Austria. The product has been distributed nationwide within the United States.
Patients who have this medication should contact their healthcare provider for guidance. Healthcare providers should not dispense the affected lots and should quarantine any remaining stock.
The recalled product
- Product
- CLEVIPREX (CLEVIPIDINE)
- Brand
- CLEVIPREX
- Manufacturer
- Chiesi USA, Inc.
- Category
- Drug — Injectable / Intravenous
- Affected units
- 44,280
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 1239521
- 1237454
- Exp. Date 10/2027
Distribution
Distributed nationwide across the United States.
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