Class II · Moderate risk Terminated
Aplicare Povidone-Iodine Prep Pad
Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Symbio Muc Eye
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
ChloraPrep OneStep
Reason 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 Terminated
Aminocaproic Acid
Reason CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
Class II · Moderate risk Terminated
Procrit
Reason Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Class II · Moderate risk Terminated
Tyvaso
Reason CGMP Deviations
Class II · Moderate risk Terminated
Acarbose Tablets
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct expiration date of July 2017.
Class II · Moderate risk Terminated
Sterile Eyewash
Reason Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk Terminated
Sterile Eyewash
Reason Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk Terminated
Sterile Eyewash
Reason Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk Terminated
Sterile Eyewash
Reason Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk Terminated
Alcohol Prep Pads
Reason Lack of Assurance of Sterility and cGMP Deviations
Class II · Moderate risk Terminated
Urin D/S Tablets Methenamine 81.6 mg
Reason Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or Superpotent tablets.
Class II · Moderate risk Terminated
Sterile Water for Injection
Reason Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
Class II · Moderate risk Terminated
Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 30 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag Rx Only
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 30 units added to 500 mL 5% Dextrose/Lactated Ringer's…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 30 units added to 1000 mL 5% Dextrose/Lactated Ringer's…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 20 units added to 500 mL Lactated Ringer's Injection USP…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection…
Reason Subpotent Drug