Class II · Moderate risk Terminated
Sato Clear
Reason Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Optic Splash
Reason Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Class II · Moderate risk Terminated
HealthA2Z CHEWABLE Aspirin
Reason cGMP deviations - presence of rubber particles found loose in the bulk product.
Class II · Moderate risk Terminated
Famciclovir tablets
Reason Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
Class II · Moderate risk Terminated
Kojic Acid 8%/Azelaic Acid 15% Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Intimate Bleaching Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Gentle Supreme Bleaching Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Custom Lightening/Brightening Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Sulfur 5% Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Sulfacetamide 10%/Hydrocortisone 1% Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Hydrocortisone 2.5% With Aloe Vera Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Metronidazole 1% Gel
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Azelaic Acid 15% Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
LIDOCAINE CREAM in all strengths including: 5%
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Retin-A 0.05% Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Purified Water
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Melatonin 1.5mg Spray
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Tretinoin 0.02% in Oil Free Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
TRETINOIN CREAM in all strengths including: 0.1%
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Hydroquinone 28% Solution
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
HYDROQUINONE CREAM in all strengths including: 4%
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
HUMAN CHORIONIC GONADOTROPIN in 300IU and 500 IU TABLETS
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
HCG in all strength including: 2
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Enhanced Retin Anti-Wrinkle Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Enhanced Retin Anti-Wrinkle Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.