CLASS II Drug recall · Reported 2 Oct 2019 · FDA Enforcement Report
Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe recalled
Cardinal Health is recalling Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For, distributed nationwide in the US. The recall was initiated on 6 Sep 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1876-2019
- FDA event ID
- 83731
- Recalling firm
- Cardinal Health, La Vergne, TN
- Brand
- Nucala
- Manufacturer
- GlaxoSmithKline LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Sep 2019
- FDA classified
- 20 Sep 2019
- Reported
- 2 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Sep 2019 | Recall initiated by company | |
| 20 Sep 2019 | Classified by FDA | +14 days |
| 2 Oct 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Which lots are affected?
Lot #: S25X, Exp. 03/31/21
Where was it sold?
Nationwide in the U.S.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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