Class II · Moderate risk
Furosemide Tablets
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Furosemide 20 mg/mL svn Sol
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
Furosemide 20 mg/mL svn Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Drug: Furosemide
- Recalling firm
- Western Drug
- Origin
- AZ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0405-2016 · 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 III · Low risk
FUROSEMIDE Tablets USP
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Other recalls by Western Drug
All 2015 recalls
Class II · Moderate risk
Salicylic Acid Inj
Lack of Assurance of Sterility
Class II · Moderate risk
Quad Mix Strong Inj
Lack of Assurance of Sterility
Class II · Moderate risk
Tri-Mix LOW ED Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcin40/Lido5 mg/mL Sus
Lack of Assurance of Sterility
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