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%.
FDA Drug Recalls
1,134 recalls, newest first
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 I · High risk
Enhanced Vegetal Vigra 200 mg Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil.
Class III · Low risk
Fluocinonide Gel USP
Cross contamination with other products: traces of Dapsone were found in the finished product.
Class II · Moderate risk
Symbio Muc Eye
Lack of Assurance of Sterility
Class I · High risk
grande X 5800 capsule
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Class I · High risk
FIFTY SHADES 6000 capsule
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Class I · High risk
PapaZen 3300 capsule
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Class I · High risk
RHINO 7 Platinum 5000
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Class I · High risk
Intralipid 20%
Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.
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 III · Low risk
Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz.
Failed Stability Specifications
Class III · Low risk
Magnesium Citrate Oral Solution Cherry Flavor
Failed Impurities/Degradation Specifications.
Class III · Low risk
Magnesium Citrate Oral Solution Lemon Flavor
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
TYVASO (treprostinil)
CGMP Deviations
Class III · Low risk
AndroGel (testosterone gel)
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.