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%.
FDA Drug Recalls
893 recalls · Class II, newest first
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
Symbio Muc Eye
Lack of Assurance of Sterility
Class II · Moderate risk
ChloraPrep OneStep
Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange)
Class II · Moderate risk
Aminocaproic Acid
CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
Class II · Moderate risk
Procrit (epoetin alfa)
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Class II · Moderate risk
TYVASO (treprostinil)
CGMP Deviations
Class II · Moderate risk
Acarbose Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct expiration date of July 2017.
Class II · Moderate risk
Sterile Eyewash
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk
Sterile Eyewash
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.