PlainRecalls
FDA Drug Moderate 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.

Reported: October 2, 2019 Initiated: September 6, 2019 #D-1876-2019

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.

Details

Units Affected
38 syringes
Distribution
Nationwide in the U.S.
Location
La Vergne, TN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Cardinal Health dba Specialty Pharmaceutical Services. Units affected: 38 syringes.
Why was this product recalled?
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 2, 2019. Severity: Moderate. Recall number: D-1876-2019.