Recalls / Class II
Class IID-1876-2019
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.
- Brand name
- Nucala
- Generic name
- Mepolizumab
- Active ingredient
- Mepolizumab
- Route
- Subcutaneous
- NDCs
- 0173-0881, 0173-0892, 0173-0904
- FDA application
- BLA125526
- Affected lot / code info
- Lot #: S25X, Exp. 03/31/21
Why it was recalled
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Recalling firm
- Firm
- Cardinal Health dba Specialty Pharmaceutical Services
- Manufacturer
- GlaxoSmithKline LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 15 Ingram Blvd, La Vergne, Tennessee 37086-3630
Distribution
- Quantity
- 38 syringes
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2019-09-06
- FDA classified
- 2019-09-20
- Posted by FDA
- 2019-10-02
- Terminated
- 2020-10-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1876-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.