FDARecall 99705Medicines
What to do
The FDA record of this recall has no instruction for consumers. Compare the lot codes below with your product. If they match, do not use it, and follow the notice of the firm or ask the store where you bought it. Talk to your pharmacist or doctor before stopping a medicine.Note from Recalls Watch, not agency text.
Read the official notice on accessdata.fda.gov (opens in a new tab)
Hazard
Why it was recalled
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
FDA classification: Class III. Use is not likely to cause adverse health consequences. Status: Ongoing.
Is it yours? Products and codes
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
- Lot or code
- Lot#: 1221973, Exp 3/24/2027
- FDA recall number
- D-0838-2026
- Quantity
- 3,002 vials
Distribution (FDA): MO, TN
About this record
- Issued by
- U.S. Food and Drug Administration
- Firm
- Chiesi USA, Inc.
- Title
- Composed by Recalls Watch from fields of the record; FDA records have no title.