Class II · Moderate risk
Tri-Immune Boost Glutathione 200 mg/mL Ascorbic Acid 200 mg/mL…
Lack of assurance of sterility.
FDA Drug Recalls
104 recalls, newest first
Class II · Moderate risk
Testosterone Cypionate 200 mg/mL in Sesame Oil
Lack of assurance of sterility.
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
Zonisamide Capsules
cGMP deviations
Class II · Moderate risk
Zonisamide Capsules
cGMP deviations
Class II · Moderate risk
Zonisamide Capsules USP
cGMP deviations
Class II · Moderate risk
Trulicity (dulaglutide)
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
Class II · Moderate risk
Trulicity (dulaglutide)
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class I · High risk
Humalog KwikPen
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class II · Moderate risk
Magnesium Hydroxide 1200mg
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk
Milk of Magnesia USP
CGMP Deviations: Failure to properly investigate failed microbial testing.