D-1876-2019 Class II Terminated

Recalled by Cardinal Health dba Specialty Pharmaceutical Services — La Vergne, TN

FDA drug recall D-1876-2019 was initiated by Cardinal Health dba Specialty Pharmaceutical Services on September 6, 2019 and is designated Class II. Reason for recall: Temperature Abuse; Product stored and shipped outside of labeled storage requirements. The recall status is terminated (terminated October 8, 2020). Affected quantity: 38 syringes.

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