FDARecall 99523Medicines
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
Lack of Assurance of Sterility
FDA classification: Class II. Use may cause temporary or medically reversible health consequences, or the chance of serious consequences is remote. Status: Ongoing.
Is it yours? Products and codes
Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01
- Lot or code
- Lot: 8494000002, Exp 7/31/28
- FDA recall number
- D-0767-2026
- Quantity
- 21,353 vials
Distribution (FDA): USA Nationwide
About this record
- Issued by
- U.S. Food and Drug Administration
- Firm
- Regeneron Pharmaceuticals Inc
- Title
- Composed by Recalls Watch from fields of the record; FDA records have no title.