Class II
Terminated
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.
This recall has been terminated (originally issued October 2, 2019).
- Recall Initiated
- September 6, 2019
- Posted
- October 2, 2019
- Recall Number
- D-1876-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 38 syringes
- Firm Location
- La Vergne, TN, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Distribution
Nationwide in the U.S.
Lot / Code Info
Lot #: S25X, Exp. 03/31/21
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