D-0838-2026 Class III Ongoing
FDA drug recall D-0838-2026 was initiated by Chiesi USA, Inc. on August 19, 2026 and is designated Class III. Reason for recall: Failed Stability Specifications: Out of specification stability result for the protein concentration profile. The recall status is ongoing. Affected quantity: 3,002 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- September 9, 2026
- Initiation Date
- August 19, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,002 vials
Product Description
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
Reason for Recall
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Distribution Pattern
MO, TN
Code Information
Lot#: 1221973, Exp 3/24/2027