Class II · Moderate risk
HYDROmorphone 20 mg/100 mL Injectable Solution
Sub-potency
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Revonto (dantrolene sodium for injection)
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
Class II · Moderate risk
Carvedilol Tablets
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Class II · Moderate risk
Acyclovir Tablets
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Class II · Moderate risk
Divalproex Sodium Extended-Release Tablets
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Class II · Moderate risk
Unison Hand Care Products
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
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
Sani-Guard-SF Waterless Foam Hand Sanitizer
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
Mild Health Care Antibacterial Hand Soap
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
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 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.