Recalls / Class I
Class ID-0234-2024
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
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).
- Brand name
- Sodium Bicarbonate
- Generic name
- Sodium Bicarbonate
- Active ingredient
- Sodium Bicarbonate
- Route
- Intravenous
- NDCs
- 0409-6637, 0409-4916
- FDA application
- ANDA202494
- Affected lot / code info
- Lot HA7295, EXP 03/01/2025
Why it was recalled
Presence of Particulate Matter; identified as glass
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 21200 Cartons
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2023-12-21
- FDA classified
- 2024-01-17
- Posted by FDA
- 2024-01-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0234-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.