Class II · Moderate risk
Sodium Selenite 200 mg/mL
Lack of assurance of sterility.
FDA Drug Recalls
6,161 recalls · Class II, newest first
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
Sermorelin Acetate 1 mg/mL
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
PT-141 (Bremelanotide Acetate)
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Melanotan II 1 mg/mL
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
LL-37 2 mg/mL
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Ipamorelin Acetate/Sermorelin Acetate
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
BPC-157 2 mg/mL
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
ARA-290 (Cibinetide Acetate)
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Testosterone Cypionate *gs*
Lack of sterility assurance.
Class II · Moderate risk
TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable
Lack of sterility assurance.
Class II · Moderate risk
TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil
Lack of sterility assurance.
Class II · Moderate risk
TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable
Lack of sterility assurance.