DrugFeb 7, 2018
Medline Catheter Insertion Kit, Sterile recall — FDA D-0276-2018
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class IIFDA: TerminatedMedline Industries Inc.
Monthly breakdown
2018 recalls by month
Select a month to review the recall records reported during that period.
December 2018285 records · 4 categoriesNovember 2018342 records · 4 categoriesOctober 2018626 records · 4 categoriesSeptember 2018393 records · 4 categoriesAugust 2018569 records · 4 categoriesJuly 2018356 records · 4 categoriesJune 2018402 records · 4 categoriesMay 2018613 records · 4 categoriesApril 2018449 records · 3 categoriesMarch 2018523 records · 3 categoriesFebruary 2018612 records · 3 categoriesJanuary 2018290 records · 3 categories
2018 recalls — page 214
Records are ordered by the best available source date.
DrugFeb 7, 2018
Medline Circumcision Tray Kit, Sterile, Single use only recall — FDA D-0275-2018
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class IIFDA: TerminatedMedline Industries Inc.
DrugFeb 7, 2018
Medline Sheath Removal Kit, Sterile, Single use only recall — FDA D-0269-2018
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class IIFDA: TerminatedMedline Industries Inc.
DrugFeb 7, 2018
A&H Focal Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign recall — FDA D-0554-2018
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products…
Class IFDA: TerminatedA&H Focal Inc.
DrugFeb 7, 2018
A&H Focal DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in recall — FDA D-0569-2018
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products…
Class IFDA: TerminatedA&H Focal Inc.
DrugFeb 7, 2018
Medline Trunk Kit, Non-sterile recall — FDA D-0262-2018
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class IIFDA: TerminatedMedline Industries Inc.
DrugFeb 7, 2018
Medline Suture Removal Pack Latex Safe, Sterile, Single Use Only recall — FDA D-0312-2018
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class IIFDA: TerminatedMedline Industries Inc.
DrugFeb 7, 2018
Medline I&D Tray Kit, Sterile, Single use only recall — FDA D-0268-2018
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class IIFDA: TerminatedMedline Industries Inc.
DrugFeb 7, 2018
Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g recall — FDA D-0336-2018
CGMP Deviations: Market complaints related to "gritty texture".
Class IIFDA: TerminatedGlenmark Pharmaceuticals Inc., USA
DrugFeb 7, 2018
A&H Focal YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language recall — FDA D-0567-2018
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products…
Class IFDA: TerminatedA&H Focal Inc.
DrugFeb 7, 2018
Medline DC Line Kit, Sterile, Single use only recall — FDA D-0272-2018
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class IIFDA: TerminatedMedline Industries Inc.
DrugFeb 7, 2018
Medline Incision and Drainage Tray, Sterile, Single Use Only recall — FDA D-0308-2018
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class IIFDA: TerminatedMedline Industries Inc.
DrugFeb 7, 2018
Medline Suture Removal Tray, Sterile, Single Use Only recall — FDA D-0289-2018
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class IIFDA: TerminatedMedline Industries Inc.
DrugFeb 7, 2018
Medline Hip Replacement, Kit, Sterile, Single Use Only recall — FDA D-0304-2018
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class IIFDA: TerminatedMedline Industries Inc.
DrugFeb 7, 2018
Medline Suture Removal Tray, Sterile, Single Use Only recall — FDA D-0310-2018
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class IIFDA: TerminatedMedline Industries Inc.
DrugFeb 7, 2018
Medline IV Start Kit, Sterile, Single use only recall — FDA D-0265-2018
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class IIFDA: TerminatedMedline Industries Inc.
DrugFeb 7, 2018
Medline Skin Stapler RMVR, Tray Sterile, Single Use Only recall — FDA D-0314-2018
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class IIFDA: TerminatedMedline Industries Inc.
DrugFeb 7, 2018
A&H Focal Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language recall — FDA D-0568-2018
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products…
Class IFDA: TerminatedA&H Focal Inc.
DrugFeb 7, 2018
A&H Focal Tiger King tablets, labeling is in foreign language recall — FDA D-0572-2018
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products…
Class IIFDA: TerminatedA&H Focal Inc.
DrugFeb 7, 2018
Medline Wound Closure Tray, Sterile, Single use only recall — FDA D-0270-2018
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class IIFDA: TerminatedMedline Industries Inc.
DrugFeb 7, 2018
Medline TRAY, CATHETER CARE, LIDDED recall — FDA D-0263-2018
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class IIFDA: TerminatedMedline Industries Inc.
DrugFeb 7, 2018
A&H Focal Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language recall — FDA D-0552-2018
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products…
Class IIFDA: TerminatedA&H Focal Inc.
DrugFeb 7, 2018
Medline Irrigation W/Piston SYR Tray, Sterile, Single Use Only recall — FDA D-0297-2018
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class IIFDA: TerminatedMedline Industries Inc.
DrugFeb 7, 2018
JCB Laboratories Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use recall — FDA D-0246-2018
Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
Class IIIFDA: TerminatedJCB Laboratories LLC
About the 2018 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.