Class II · Moderate risk
Mild Health Care Antibacterial Hand Soap
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
FDA Drug Recalls
1,563 recalls, newest first
Class II · Moderate risk
Antibacterial Hand Soap
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
INODERM Antiseptic Hand Soap
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
Instant Waterless Hand Sanitizer
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
AQUACIL instant foaming hand sanitizer
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
Losartan Potassium/HCTZ
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
Class III · Low risk
Carvedilol Tablets
Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.
Class I · High risk
FENTANYL Transdermal System
Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
Class II · Moderate risk
BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal…
Defective Delivery System: difficult to express
Class II · Moderate risk
Volumex (Iodinated I 131 Albumin)
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Class II · Moderate risk
DelNido Cardioplegia
Lack of sterility assurance.
Class II · Moderate risk
Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Vancomycin 1500 mg in NS 250 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Vancomycin 1250 mg in NS 250 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Vancomycin 1000 mg in NS 250 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Sodium Citrate 4%
Lack of sterility assurance.
Class II · Moderate risk
Sodium Bicarbonate 150 mEq in D5W 1000 mL bags
Lack of sterility assurance.
Class II · Moderate risk
Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Phenylephrine 20 mg NS 250 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Phenylephrine 0.8 mg/10 mL NS
Lack of sterility assurance.
Class II · Moderate risk
Heparin Pork 30
Lack of sterility assurance.
Class II · Moderate risk
Chlorothiazide 100 mg
Lack of sterility assurance.