Drug 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.
D-1876-2019
Product summary
- Event
- Event 83731
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38 syringes
- Official record key
drug-enforcement:D-1876-2019
Official wording
Reason: Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Code information: Lot #: S25X, Exp. 03/31/21
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Unknown
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.