FDA Drug recall D-1876-2019
Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only, Manufactured by GlaxoSmithKli…
- FDA Drug
- Class II
- terminated
- Published 2019-10-02
On 2019-10-02 the FDA classified a Class II recall of Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only, Manufactured by GlaxoSmithKli… by Cardinal Health, citing temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1876-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-06 |
| Published | 2019-10-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Health |
| Distribution | US |
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
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Identifiers
| ndc | 0173-0881-01 |
|---|---|
| ndc | 0173-0881-61 |
| ndc | 0173-0892-01 |
| ndc | 0173-0892-42 |
| ndc | 0173-0892-61 |
| ndc | 0173-0892-63 |
| ndc | 0173-0904-42 |
| code_info | Lot #: S25X, Exp. 03/31/21 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1876-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.