FDA (Drugs) recall action 78575
The FDA (Drugs) publishes a recall like this one as 68 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 68 pages.
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medline Industries is recalling 231 cases of Trunk Kits because the Povidone-Iodine prep pads contain less iodine than labeled.
Medline Industries is recalling Suture Removal Kits because the iodine concentration is below the labeled claim of 0.85%.
Medline Industries is recalling Povidone-Iodine prep pads because the iodine content is below the labeled claim of 0.85%.
Medline Industries is recalling Vaginal Delivery CDS Packs because the iodine content is below the label claim.
Medline Industries is recalling Suture Removal Trays because the iodine concentration is below the labeled claim.
Medline Industries is recalling DC Line Kits because the iodine concentration in the prep pads is below the labeled claim.
Medline Industries is recalling 40 cases of Sheath Removal Kits because the iodine concentration is below the labeled claim.
Medline Industries is recalling sterile staple remover trays containing subpotent povidone-iodine prep pads. The iodine concentration is below the labeled claim of 0.85%.
Medline Industries is recalling sterile catheter insertion trays because the iodine concentration in the prep pads is below the labeled claim.
Medline Industries is recalling 9,000 cases of Suture Removal Trays because the iodine concentration in the prep pads is below the labeled claim.
Medline is recalling Central Line Dressing Change Tray Kits because the iodine concentration in the prep pads is below the label claim.
Medline Industries is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than the label claims.
Medline Industries is recalling General Purpose Kits because the Povidone-Iodine prep pads contain less iodine than the label claims.
Medline Industries is recalling Pediatric IV Kits because the Povidone-Iodine prep pads contain less iodine than labeled.
Medline Industries is recalling IV Start Kits because the Povidone-Iodine prep pads contain less iodine than labeled.
Medline Industries is recalling suture removal trays because the povidone-iodine prep pads contain less iodine than labeled.
Medline Industries is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than labeled.
Medline Industries is recalling Dressing Change Tray Kits because the Povidone-Iodine prep pads contain less iodine than the label claims.