Class II · Moderate risk Terminated
Acyclovir Tablets
Reason Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Divalproex Sodium Extended-Release Tablets
Reason cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Class II · Moderate risk Terminated
Unison Hand Care Products
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
Antibacterial Hand Soap
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
Sani-Guard-SF Waterless Foam Hand Sanitizer
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
Mild Health Care Antibacterial Hand Soap
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
Antibacterial Hand Soap
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
INODERM Antiseptic Hand Soap
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
Instant Waterless Hand Sanitizer
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
AQUACIL instant foaming hand sanitizer
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as…
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
Losartan Potassium/HCTZ
Reason 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 II · Moderate risk Terminated
BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal…
Reason Defective Delivery System: difficult to express
Class II · Moderate risk Terminated
Volumex
Reason Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Class II · Moderate risk Terminated
DelNido Cardioplegia
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Vancomycin 1500 mg in NS 250 mL bag
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Vancomycin 1250 mg in NS 250 mL bag
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Vancomycin 1000 mg in NS 250 mL bag
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Sodium Citrate 4%
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Sodium Bicarbonate 150 mEq in D5W 1000 mL bags
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Phenylephrine 20 mg NS 250 mL bag
Reason Lack of sterility assurance.