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.
FDA Drug Recalls
1,134 recalls, newest first
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 I · High risk
XtraHRD Natural Male Enhancement Capsules
Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tadalafil which is an active pharmaceutical ingredient in a FDA approved drug used to treat erectile dysfunction (ED).
Class II · Moderate risk
HealthA2Z CHEWABLE Aspirin
cGMP deviations - presence of rubber particles found loose in the bulk product.
Class III · Low risk
Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9%…
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9%…
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in…
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9%…
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9%…
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9%…
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9%…
Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk
Famciclovir tablets
Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
Class III · Low risk
Zenatane (isotretinoin)
Failed dissolution specifications - low dissolution results at S3 stage.
Class III · Low risk
Zenatane (isotretinoin)
Failed dissolution specifications - low dissolution results at S3 stage.
Class III · Low risk
Zenatane (isotretinoin)
Failed dissolution specifications - low dissolution results at S3 stage.
Class III · Low risk
Zenatane (isotretinoin)
Failed dissolution specifications - low dissolution results at S3 stage.
Class III · Low risk
PreviDent 5000 ppm
Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
Class III · Low risk
Salicylic Acid Cream
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Class III · Low risk
Salicylic Acid Shampoo
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
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.