Drug product
8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 50 mL Syringe per Carton, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6637-24 (carton), 0409-6637-14 (case).
D-0234-2024
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 93681
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 21200 Cartons
- Official record key
drug-enforcement:D-0234-2024
Official wording
Reason: Presence of Particulate Matter; identified as glass
Code information: Lot HA7295, EXP 03/01/2025
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter