Class II · Moderate risk Terminated
Edex
Reason Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
FDA Drug Recalls
14,801 recalls, newest first
Class III · Low risk Terminated
A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%
Reason Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
Class II · Moderate risk Terminated
VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk Terminated
VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk Terminated
VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk Terminated
Potassium PHOSphate added to 0.9% Sodium Chloride
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk Terminated
Potassium PHOSphate added to 0.9% Sodium Chloride
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk Terminated
Potassium PHOSphate added to 0.9% Sodium Chloride
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk Terminated
Potassium PHOSphate added to 0.9% Sodium Chloride
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk Terminated
Potassium PHOSphate added to 0.9% Sodium Chloride
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk Terminated
Potassium PHOSphate in 0.5% Dextrose
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk Terminated
Potassium CHLORide added to 0.9% Sodium Chloride
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk Terminated
Potassium CHLORide added to 0.9% Sodium Chloride
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk Terminated
Risedronate Sodium Delayed-release Tablets
Reason Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
Class II · Moderate risk Terminated
Dorama-Neo
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
Sato Clear
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
Optic Splash
Reason Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Class I · High risk Terminated
XtraHRD Natural Male Enhancement Capsules
Reason 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 Terminated
HealthA2Z CHEWABLE Aspirin
Reason cGMP deviations - presence of rubber particles found loose in the bulk product.
Class III · Low risk Terminated
Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9%…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9%…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9%…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9%…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9%…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date