Class II · Moderate risk Terminated
17-0h Progesterone 250mg/Ml
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Sulfacetamide Sodium Ophthalmic Solution
Reason Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Class III · Low risk Terminated
VP-CH-PNV Prenatal/Postnatal capsules
Reason Defective delivery system: Softgel capsules are leaking.
Class II · Moderate risk Terminated
Potassium CHLORide added to 5% Dextrose Injection
Reason Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.
Class II · Moderate risk Terminated
HCL 2mg/Ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Zinc So4 1mg/Ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Arginine 100mg/Ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Zinc So4 10mg/Ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Zinc Chloride 10mg/Ml in Nacl 0.29%
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Tryptophan 10mg/Ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Tmg 100 Mg/Ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Thiamine 100 Mg/Ml W/Pres
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Thiamine 100 Mg/Ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Testosterone Cyp 50 Mg/Ml W/Pres
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Testosterone Cyp 25 Mg/Ml W/Pres
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Testosterone Cyp 20 Mg/Ml W/Pres
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Testosterone Cyp 200 Mg/Ml W/Pres
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Testosterone Cyp 100 Mg/Ml W/Pres
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Taurine 50 Mg/Ml W/Pres.
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Taurine 50 Mg/Ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Selenium 200mcg/Ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Riboflavin 10mg/Ml
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Pyridoxine HCL 100mg/Ml W/Pres
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Pyridoxine HCL 100mg/Ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Pyridoxal 50 Mg/Thiamine 50 Mg/Lidocaine 1% Ns
Reason Lack of Assurance of Sterility