Chiesi Recalls Revcovi Injection Due to Stability Specification Failure
Chiesi USA is recalling 3,002 vials of Revcovi (elapegademase-lvlr) injection because the product failed stability specifications for protein concentration.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which is defined as a situation where use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Plain-English summary
Chiesi USA, Inc. is recalling 3,002 vials of Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial. The product is a prescription-only medication intended for intramuscular use. The recall involves Lot #1221973, which has an expiration date of 3/24/2027.
The recall was initiated because the product failed stability specifications, specifically regarding an out-of-specification stability result for the protein concentration profile. This indicates that the product may not maintain its intended quality or potency over time.
The affected product was distributed to Missouri and Tennessee. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider or Chiesi USA for further instructions.
The recalled product
- Product
- REVCOVI (ELAPEGADEMASE-LVLR)
- Brand
- REVCOVI
- Manufacturer
- Chiesi USA, Inc.
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 3,002
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 (2)
- Lot#: 1221973
- Exp 3/24/2027
Distribution
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