Class II · Moderate risk
Dopamine HCl Inj.
Lack of Assurance of Sterility
Vial Label: 8.4% Sodium Bicarbonate Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.
Affected NDCs
0409-6637-14
0409-6637-24
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Sodium Bicarbonate NDC 00409-6637 |
84 mg/mL | Injection, Solution Intravenous |
Hospira, Inc. | Rx |
- Recalling firm
- Pfizer INC
- NDC code
- 0409-6637-24
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0591-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
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Class II · Moderate risk
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Class II · Moderate risk
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Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
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