Class II · Moderate risk
Testosterone Cypionate 200 mg/mL in Sesame Oil
Lack of assurance of sterility.
FDA Drug Recalls
1,206 recalls · Class II, newest first
Class II · Moderate risk
Testosterone Cypionate 200 mg/mL in Grapeseed Oil
Lack of assurance of sterility.
Class II · Moderate risk
T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL
Lack of assurance of sterility.
Class II · Moderate risk
T-105 Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL
Lack of assurance of sterility.
Class II · Moderate risk
Sodium Tetradecyl Sulfate 5% MDV Injection
Lack of assurance of sterility.
Class II · Moderate risk
Sodium Tetradecyl Sulfate 1.5% MDV Injection
Lack of assurance of sterility.
Class II · Moderate risk
Sodium Tetradecyl Sulfate 0.3% Injection
Lack of assurance of sterility.
Class II · Moderate risk
Sodium Selenite 200 mg/mL
Lack of assurance of sterility.
Class II · Moderate risk
Sodium Bicarbonate 8.4% MDV Injection
Lack of assurance of sterility.
Class II · Moderate risk
Diluent for Reconstitution Multi-Dose 10 mL vial
Lack of assurance of sterility.
Class II · Moderate risk
Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial
Lack of assurance of sterility.
Class II · Moderate risk
SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL
Lack of assurance of sterility.
Class II · Moderate risk
SB-5 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 50 mcg/mL
Lack of assurance of sterility.
Class II · Moderate risk
RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL
Lack of assurance of sterility.
Class II · Moderate risk
RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL
Lack of assurance of sterility.
Class II · Moderate risk
QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine 0.2 mg/mL
Lack of assurance of sterility.
Class II · Moderate risk
medroxyPROGESTERone Acetate Injectable Suspension
Lack of assurance of sterility
Class II · Moderate risk
medroxyPROGESTERone Acetate Injectable Suspension
Lack of assurance of sterility
Class II · Moderate risk
medroxyPROGESTERone Acetate Injectable Suspension
Lack of assurance of sterility
Class II · Moderate risk
medroxyPROGESTERone Acetate Injectable Suspension
Lack of assurance of sterility
Class II · Moderate risk
medroxyPROGESTERone Acetate Injectable Suspension
Lack of assurance of sterility
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: customer complaints exceeded respective action limits.
Class II · Moderate risk
Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Equate Tartar Control Plus
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
Losartan HCTZ 50/12.5 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits