Class II · Moderate risk
Furosemide Tablets
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Furosemide Injection USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
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
Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102-04
Affected NDC
0409-6102-04
Compare with the code on your package — it is the most precise check available.
Drug: Furosemide
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 |
|---|---|---|---|---|
| Furosemide NDC 00409-6102 |
10 mg/mL | Injection, Solution Intramuscular|intravenous |
Hospira, Inc. | Rx |
- Recalling firm
- Hospira, Inc.
- NDC code
- 0409-6102-04
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-169-2013 · 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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Furosemide recalls
See all
Class II · Moderate risk
Furosemide Tablets
Presence of Foreign Substance
Class I · High risk
Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection
Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Class II · Moderate risk
Furosemide Tablets USP
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Class II · Moderate risk
Furosemide 20 mg/mL svn Sol
Lack of Assurance of Sterility
Other recalls by Hospira, Inc.
All 2013 recalls
Class I · High risk
Infant 25% DEXTROSE Injection
Presence of Particulate Matter: human hair found within an internal sample syringe.
Class II · Moderate risk
Fentanyl Citrate Injection
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Class II · Moderate risk
DOBUTamine Injection
Discoloration: Firm received complaints of product discoloration and particulates.
Class III · Low risk
5% Lidocaine HCL and 7.5% Dextrose Injection
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
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