Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Subpotent Product: assay results for Amoxicillin were below the specification limits.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Divalproex Sodium Extended-Release Tablets
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Class II · Moderate risk
GlipiZIDE Extended-release Tablets
Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
Class II · Moderate risk
TriMix MEDIUM
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Trimix HIGH
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Test PROCYP
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Test D (Testosterone Cypionate 200mg/Ml Vitamin D3 5,000iu/Ml)
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Test D (Testosterone Cypionate 200mg/Ml Vitamin D3 5,000iu/Ml)
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Lipoplex
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL)
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL…
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
BPlex
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
BPlex
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Prostaglandin Tri-Mix 30:30:1 Injection
Lack of sterility assurance.
Class II · Moderate risk
Prostaglandin Tri-Mix 20:25:1 Injection
Lack of sterility assurance.
Class II · Moderate risk
Prostaglandin Tri-Mix 8.33:22.5:0.833 Injection
Lack of sterility assurance.
Class II · Moderate risk
Prostaglandin Tri-Mix 2.5:7.5:0.25 Injection
Lack of sterility assurance.
Class II · Moderate risk
Prostaglandin Tri-Mix 5:15:0.5 Injection
Lack of sterility assurance.
Class II · Moderate risk
Phenol 10% Injection
Lack of sterility assurance.
Class II · Moderate risk
Papaverine 30 mg/mL Injection
Lack of sterility assurance.
Class II · Moderate risk
Papaverine 30 mg/Phentolamine 0.5 mg/mL
Lack of sterility assurance.
Class II · Moderate risk
Hcg 11
Lack of sterility assurance.
Class II · Moderate risk
Estrone 5mg/mL Oil Injection
Lack of sterility assurance.
Class II · Moderate risk
Heparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 mL per 75 mL
Lack of sterility assurance.
Class II · Moderate risk
Gentamicin 240 mg/500 mL Sterile Water for Irrigation
Lack of sterility assurance.