Class III · Low risk Terminated
Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9%…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Famciclovir tablets
Reason Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
Class III · Low risk Terminated
Zenatane
Reason Failed dissolution specifications - low dissolution results at S3 stage.
Class III · Low risk Terminated
Zenatane
Reason Failed dissolution specifications - low dissolution results at S3 stage.
Class III · Low risk Terminated
Zenatane
Reason Failed dissolution specifications - low dissolution results at S3 stage.
Class III · Low risk Terminated
Zenatane
Reason Failed dissolution specifications - low dissolution results at S3 stage.
Class III · Low risk Terminated
PreviDent 5000 ppm
Reason Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
Class III · Low risk Terminated
Salicylic Acid Cream
Reason Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Class III · Low risk Terminated
Salicylic Acid Shampoo
Reason Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
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.