Revcovi recall
Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc.…
Why was Revcovi recalled?
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot#: 1221973, Exp 3/24/2027
- Product
- Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc.…
- Recalling firm
- Chiesi USA, Inc.
- Quantity
- 3,002 vials
- Distribution
- MO, TN
- Recall date
- September 9, 2026
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)