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 is recalling Incision and Drainage Tray Kits because the Povidone-Iodine prep pads contain less iodine than labeled.
Medline Industries is recalling 60 cases of Anesthesia Kits because the Povidone-Iodine prep pads contain less iodine than the label claims.
Medline Industries is recalling Suture Removal Kits because the iodine concentration is below the label claim.
Medline Industries is recalling IV Start Kits because the iodine concentration in the prep pads is below the labeled claim.
Medline Industries is recalling sterile incision and drainage tray 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 80 cases of Wound Closure Trays because the iodine concentration in the prep pads is below the labeled claim of 0.85%.
Medline Industries is recalling IV Start Kits because the iodine concentration in the prep pads is below the labeled claim of 0.85%.
Medline Industries is recalling I&D Tray Kits because the Povidone-Iodine prep pads contain less iodine than the label claims.
Medline is recalling Incision Drainage Kits because the iodine content is below the labeled claim. The product was distributed nationwide and internationally.
Medline Industries is recalling sterile Povidone-Iodine prep pads because the iodine content is below the labeled 0.85% claim.
Medline Industries is recalling Circumcision Tray Kits because the iodine concentration in the prep pads is below the labeled claim.
Medline Industries is recalling CNTRL Line Removal Kit Scripps because the iodine content is below the label claim.
Medline Industries is recalling Suture Removal Kits because the iodine concentration is below the label claim of 0.85%.
Medline Industries is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than the label claims.
Medline Industries is recalling Abdominal Surgery II Packs because the iodine content in the prep pads is below the label claim.
Medline Industries is recalling specific lots of Incision Drainage Trays because the iodine concentration is below the label claim.
Medline Industries is recalling Suture Removal Trays because the iodine concentration in the prep pads is below the labeled claim of 0.85%.
Medline Industries is recalling Skin Stapler RMVR trays because the iodine concentration in the prep pads is below the labeled claim.
Medline is recalling Incision and Drainage Trays because the Povidone-Iodine prep pads contain less iodine than labeled.
Medline Industries is recalling Vitrectomy CDS Packs because the iodine concentration is below the label claim of 0.85%.
Medline Industries is recalling Debridement Trays because the iodine concentration in the prep pads is below the label claim.
Medline Industries is recalling Suture Removal Trays because the iodine content in the prep pads is below the labeled claim.
Medline Industries is recalling sterile Povidone-Iodine prep pads because the iodine content is below the label claim of 0.85%.
Medline is recalling IV Circulation Packs because the iodine prep pads contain less iodine than labeled. The product was distributed in the US and 10 other countries.