14 FDA recalls mention Furosemide. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Furosemide.
Reason CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Reason Presence of Foreign Substance
Reason Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Reason Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Reason Lack of Assurance of Sterility
Reason CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture…
Reason CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility…
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Reason Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility…
Reason Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Reason Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because…
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