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FDA · Drugs ·

Revcovi (elapegademase-lvlr) Injection recall

Chiesi USA, Inc. recalled Revcovi (elapegademase-lvlr) Injection on September 9, 2026 because of failed Stability Specifications: Out of specification stability result for the protein concentration profile. It was sold in MO, TN.

Why it was recalled

Failed Stability Specifications: Out of specification stability result for the protein concentration profile.

What's recalled

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., Cary, NC 27518, NDC 10122-502-01

Quantity: 3,002 vials

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Chiesi USA, Inc., Cary, NC
Date
Severity
Class III
the product is unlikely to cause health problems but breaks a rule.
Where sold
MO, TN
MO, TN
Status
Ongoing
Recall number
D-0838-2026
Source
U.S. Food and Drug Administration

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