Recalls / Class I
Class ID-0100-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- Lot#: GJ5007, Exp. 8/1/2024
Why it was recalled
Presence of Particulate Matter: identified as glass.
Recalling firm
- Firm
- Pfizer Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, New York, New York 10017-5703
Distribution
- Quantity
- 24,900 vials
- Distribution pattern
- Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
Timeline
- Recall initiated
- 2023-10-02
- FDA classified
- 2023-11-09
- Posted by FDA
- 2023-11-15
- Terminated
- 2025-02-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0100-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.