US Drug Recall Register
Class II · Moderate risk Terminated Initiated Sep 6, 2019 (7 years ago)

Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Temperature Abuse; Product stored and shipped outside of labeled storage requirements.

What was recalled

Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only, Manufactured by GlaxoSmithKline LLC, Philadelphia, PA 19112, Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0892-42.

Recalling firm
Cardinal Health dba Specialty Pharmaceutical Services
NDC code
0173-0892-42
Origin
TN, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1876-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.