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.

FDA recall notice · announced October 2, 2019 · Cardinal Health Dba Specialty Pharmaceutical Services

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Reason for recall

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

Notes

Distribution: Nationwide in the U.S.
Lot/code information: Lot #: S25X, Exp. 03/31/21
Quantity: 38 syringes
Status: Terminated
Products in this recall event:
- 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 GlaxoSmithKlin (D-1876-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.