D-1876-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 2, 2019
- Initiation Date
- September 6, 2019
- Termination Date
- October 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38 syringes
Product Description
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.
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot #: S25X, Exp. 03/31/21