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.
FDA Drug Recalls
14,450 recalls · Class II, newest first
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 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.
Class II · Moderate risk Terminated
Xanax XR
Reason Failed Dissolution Specifications: low out of specification results for dissolution.
Class II · Moderate risk Terminated
alprazolam XR extended-release tablets
Reason Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
Class II · Moderate risk Terminated
GaviLyte -C
Reason Failed Stability Specification
Class II · Moderate risk Terminated
Vancomycin HCl 1.5 g in 0.9% Sodium Chloride
Reason CGMP Deviations
Class II · Moderate risk Terminated
Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags
Reason CGMP Deviations
Class II · Moderate risk Terminated
Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag
Reason CGMP Deviations