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
- Recalling Firm
- Cardinal Health dba Specialty Pharmaceutical Services
- 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.
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