Class II · Moderate risk
Medline General Purpose Kit
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Wrong potency or content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk.
992 FDA drug recalls with this cause, newest first.
These recalls cover sub-potent or super-potent products, or a failed content-uniformity test - meaning some pills in the same batch held noticeably different amounts of active ingredient than others. Either way it is a direct dosing risk: too little to work, or too much and harmful. Thyroid hormones and compounded injectables are the classic examples, because their dose window is narrow.
Class II · Moderate risk
Medline Wound Closure Tray
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk
Medline Sheath Removal Kit
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk
Medline I&D Tray Kit
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk
Medline Incision and Drainage Tray Kit
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk
Medline Central Line Dressing Change Tray Kit
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk
Medline IV Start Kit
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk
Medline Suture Removal Tray. Sterile. Single use only. Packaged…
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk
Medline TRAY
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk
Medline Trunk Kit
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk
Medline CNTRL Line Removal Kit Scripps. Packaged in USA for Medline Industries
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk
Medline Pediatric IV Kit. Packaged in USA for Medline Industries
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk
Medline Concordia Nurse Bag Kit. Packaged in USA for Medline Industries
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk
Medline Concordia Trunk Kit. Packaged for Medline Industries
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk
Medline Newborn Kit. Packaged for Medline Industries
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk
Medline RAD NECK ENT TRAY Pack
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk
Medline Vitrectomy CDS Pack
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk
Medline Vaginal Delivery CDS Pack
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk
Medline CC Drawer 4 IV Circulation Pack
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk
Aplicare Povidone-Iodine Prep Pad
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk
Urin D/S Tablets Methenamine 81.6 mg
Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or Superpotent tablets.
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
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