Class II · Moderate risk
Alteplase 1 mg/mL 1 mL in 10 mL syringe
Lack of sterility assurance.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Oxytocin 30 units in NS 500 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Norepinephrine 16 mg in NS 250 mL bag
Lack of sterility assurance.
Class II · Moderate risk
NICARdipine 25 mg in NS 250 mL EXCEL bag
Lack of sterility assurance.
Class II · Moderate risk
Magnesium Sulfate 6 GM in NS 50 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Magnesium Sulfate 4 GM in NS 50 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Magnesium Sulfate 2 GM in NS 50 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Magnesium Sulfate 1 GM in NS 50 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Labetalol 20 mg/4 mL
Lack of sterility assurance.
Class II · Moderate risk
Diltiazem 250 mg in NS 250 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Clindamycin 900 mg in NS 50 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Dexmedetomidine 400 mcg in NS 100 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Subpotent Product: assay results for Amoxicillin were below the specification limits.
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.