Class III · Low risk
Clearasil Rapid Rescue Deep Treatment Pads
Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging.
FDA Drug Recalls
14,806 recalls, newest first
Class I · High risk
WEFUN Capsules 825 mg
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Class II · Moderate risk
Digoxin Tablets
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Class I · High risk
Digoxin Tablets
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Class II · Moderate risk
Doxil (doxorubicin hydrochloride liposome injection)
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Class III · Low risk
Clindamycin Phosphate Topical Solution USP
Defective Container: slow leakage under the cap
Class II · Moderate risk
Florbetaben F-18
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Class II · Moderate risk
dilTIAZem 125mg/125mL
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
dilTIAZem 125mg/125mL
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
vancomycin added to 0.9% Sodium Chloride
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
heparin added to 0.9% sodium chloride
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
oxyTOCIN
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
oxyTOCIN 30 units added to Lactated Ringer's 500 mL
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
EPINEPHrine added to dextrose 5%
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
EPINEPHrine added to 0.9% sodium chloride
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
EPINEPHrine
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
PHENYLephrine
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
PHENYLephrine added to 0.9% sodium chloride
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
PHENYLephrine
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
PHENYLephrine 1
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Cardioplegia Solution
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles