FDA Recall D-0100-2024
Pfizer Inc. · New York, NY
Class I — life-threatening Terminated 501 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Presence of Particulate Matter: identified as glass.
Recall record
- Recall number
D-0100-2024- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
- Recall initiated
- 2023-10-02
- Classified by FDA Center
- 2023-11-09
- FDA published
- 2023-11-15
- Terminated
- 2025-02-14
- Recalling firm
- Pfizer Inc.
- Firm location
- New York, NY