Class II · Moderate risk
Ropivacaine HCl in 0.9% Sodium Chloride all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Bupivacaine HCl in 0.9% Sodium Chloride all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class III · Low risk
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only
Chemical Contamination
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 III · Low risk
A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%
Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
Class II · Moderate risk
VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk
VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk
VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Potassium PHOSphate added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Potassium PHOSphate added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Potassium PHOSphate added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Potassium PHOSphate added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Potassium PHOSphate added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk
Potassium PHOSphate in 0.5% Dextrose
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Potassium CHLORide added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Potassium CHLORide added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Risedronate Sodium Delayed-release Tablets
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
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 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