FDA recall D-1876-2019

Cardinal Health dba Specialty Pharmaceutical Services · Class II · 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.

Reason for recall

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

Distribution

Nationwide in the U.S.

Key facts

Status
Terminated
Initiation date
2019-09-06
Report date
2019-10-02
Termination date
2020-10-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
La Vergne, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1876-2019