Class II · Moderate risk Terminated
Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL…
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
BPlex
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk Terminated
BPlex
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class I · High risk Terminated
Kopi Jantan Tradisional Natural Herbs Coffee
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class III · Low risk Terminated
Telmisartan and Amlodipine Tablets 80 mg/5 mg
Reason Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Class III · Low risk Terminated
Remifentanil HCl active pharmaceutical ingredient
Reason Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
Class II · Moderate risk Terminated
Prostaglandin Tri-Mix 30:30:1 Injection
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Prostaglandin Tri-Mix 20:25:1 Injection
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Prostaglandin Tri-Mix 8.33:22.5:0.833 Injection
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Prostaglandin Tri-Mix 2.5:7.5:0.25 Injection
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Prostaglandin Tri-Mix 5:15:0.5 Injection
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Phenol 10% Injection
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Papaverine 30 mg/mL Injection
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Papaverine 30 mg/Phentolamine 0.5 mg/mL
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Hcg 11
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Estrone 5mg/mL Oil Injection
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Heparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Gentamicin 240 mg/500 mL Sterile Water for Irrigation
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Gentamicin 160 mg/1000 mL Sterile Water for Irrigation
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Heparin 20
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Sodium Bicarbonate 8.4% Injection
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
EDTA 1% Sterile Injection
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Lidocaine 1%/Dextrose 12.5%
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Neomycin 40 mg/Polymixin B 200
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Prostaglandin Tri-Mix 60:30:1 Injection
Reason Lack of sterility assurance.