Class II · Moderate risk Completed
Sodium Selenite 200 mg/mL
Reason Lack of assurance of sterility.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Completed
Sodium Bicarbonate 8.4% MDV Injection
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Diluent for Reconstitution Multi-Dose 10 mL vial
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
SB-5 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 50 mcg/mL
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300…
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
medroxyPROGESTERone Acetate Injectable Suspension
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
medroxyPROGESTERone Acetate Injectable Suspension
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
medroxyPROGESTERone Acetate Injectable Suspension
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
medroxyPROGESTERone Acetate Injectable Suspension
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
medroxyPROGESTERone Acetate Injectable Suspension
Reason Lack of assurance of sterility
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: customer complaints exceeded respective action limits.
Class II · Moderate risk Terminated
Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By…
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Equate Tartar Control Plus
Reason Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification for the four active ingredients.
Class II · Moderate risk Terminated
Losartan HCTZ 50/12.5 mg
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class III · Low risk Terminated
Sirolimus Oral Solution
Reason Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Class III · Low risk Terminated
Nitrofurantoin Capsules
Reason Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Class II · Moderate risk Terminated
Losartan HCTZ 100/12.5 mg
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II · Moderate risk Terminated
Losartan HCTZ 100/25 mg
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II · Moderate risk Terminated
Mvasi
Reason Defective container: loose crimp defect, potential loss of container integrity.