Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Other Drugs
π Drugs β’ 3,200 recalls
Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release solid oral dosage forms, making this product unapproved drug for which safety and efficacy have not been establish and therefore, subject to recall.
Medline Concordia Trunk Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093
Medline Industries
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Medline Pediatric IV Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Medline Industries
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Medline RAD NECK ENT TRAY Pack, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Medline Industries
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Medline Concordia Nurse Bag Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Medline Industries
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Medline TRAY, CATHETER CARE, LIDDED. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Medline Industries
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Medline CNTRL Line Removal Kit Scripps. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Medline Industries
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Medline Anesthesia Kit, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093
Medline Industries
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Neutrogena Elevated 4-Holiday Trays (contains Neutrogena Deep Clean Purifying Whipped Foam Cleanser) Case Code: 00070501302866
Johnson & Johnson
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Microbial Contamination of Non-Sterile Products.
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland, MS, NDC 71019-263-20
Pharmedium Services
Superpotent Drug