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Recall Observatory FDA recall evidence

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

October 02, 2023

Class I

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

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter