Drug product
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24
D-0100-2024
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 93124
- Status
- Terminated
- Classification
- Class I
- Quantity
- 24,900 vials
- Official record key
drug-enforcement:D-0100-2024
Official wording
Reason: Presence of Particulate Matter: identified as glass.
Code information: Lot#: GJ5007, Exp. 8/1/2024
Distribution pattern: Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter