Class II · Moderate risk
Edex (alprostadil for injection)
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
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
VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk
VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk
VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk
Potassium PHOSphate in 0.5% Dextrose
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk
Dorama-Neo
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Class II · Moderate risk
Sato Clear
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Class II · Moderate risk
Optic Splash
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Class II · Moderate risk
HealthA2Z CHEWABLE Aspirin
cGMP deviations - presence of rubber particles found loose in the bulk product.
Class II · Moderate risk
Famciclovir tablets
Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
Class II · Moderate risk
Kojic Acid 8%/Azelaic Acid 15% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Intimate Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Gentle Supreme Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Custom Lightening/Brightening Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Sulfur 5% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Sulfacetamide 10%/Hydrocortisone 1% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Hydrocortisone 2.5% With Aloe Vera Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Metronidazole 1% Gel
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Azelaic Acid 15% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
LIDOCAINE CREAM in all strengths including: 5%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Retin-A 0.05% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Purified Water
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Melatonin 1.5mg Spray
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Tretinoin 0.02% in Oil Free Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
TRETINOIN CREAM in all strengths including: 0.1%
Lack of Assurance of Sterility: There are also CGMP Deviations.