Class II · Moderate risk
Ciprofloxacin in Dextrose
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
FDA Drug Recalls
387 recalls, newest first
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 · 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
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.
Class II · Moderate risk
Hydroquinone 28% Solution
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
HYDROQUINONE CREAM in all strengths including: 4%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
HUMAN CHORIONIC GONADOTROPIN in 300IU and 500 IU TABLETS
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
HCG in all strength including: 2
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Enhanced Retin Anti-Wrinkle Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.