16 FDA recalls mention Ferric. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ferric.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914…
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Failed Dissolution Specifications
Reason CGMP Deviations
Reason cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Reason Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of…
Reason Lack of Assurance of Sterility
Reason Superpotent Drug: contains higher levels of Iron than labeled.
Reason cGMP violations noted during the firm's most recent inspection.
Reason cGMP violations noted during the firm's most recent inspection.
Reason CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica…
Reason Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
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…
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