Drug product
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 0409-5534-24 (carton), 0409-5534-14 (case).
D-0233-2024
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 93681
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 34000 Cartons
- Official record key
drug-enforcement:D-0233-2024
Official wording
Reason: Presence of Particulate Matter; identified as glass
Code information: Lot GX1542, Exp. 01/01/2025
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter