Why it was recalled
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
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.
Lot numbers, UPCs & expiration codes
Lot #: S25X, Exp. 03/31/21
Where it was sold
Nationwide in the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1876-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 6, 2019
- FDA report date
- Oct 2, 2019
- Quantity
- 38 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cardinal Health dba Specialty Pharmaceutical Services
Original FDA data
Every field from FDA enforcement report D-1876-2019, exactly as published.
Show all FDA fields
- City
- La Vergne
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 83731
- Address
- 15 Ingram Blvd
- Code information
- Lot #: S25X, Exp. 03/31/21
- Postal code
- 37086-3630
- Report date
- Oct 2, 2019
- Product type
- Drugs
- Recall number
- D-1876-2019
- Classification
- Class II
- Recalling firm
- Cardinal Health dba Specialty Pharmaceutical Services
- Product quantity
- 38 syringes
- Termination date
- Oct 8, 2020
- Reason for recall
- Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Sep 6, 2019
- Initial firm notification
- Letter
- Center classification date
- Sep 20, 2019