Class III · Low risk
Potassium PHOSphate added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
FDA drug recalls in 2017
Every FDA drug recall initiated in 2017, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,141 recalls, newest first.
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
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.