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 drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
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 II · Moderate risk
Symbio Muc Eye
Lack of Assurance of Sterility
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 II · Moderate risk
TYVASO (treprostinil)
CGMP Deviations
Class II · Moderate risk
Acarbose Tablets
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
Sterile Eyewash
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk
Sterile Eyewash
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk
Sterile Eyewash
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk
Sterile Eyewash
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk
Alcohol Prep Pads
Lack of Assurance of Sterility and cGMP Deviations
Class II · Moderate risk
Urin D/S Tablets Methenamine 81.6 mg
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
Sterile Water for Injection
Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk