Class II · Moderate risk Terminated
CefTRIAXone 1 GM
Reason Lack of sterility assurance.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
CeFAZolin 3 gm 100 mg/mL
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
CeFAZolin 2 GM a) in NS 100 mL bag
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
CeFAZolin 1 GM a) in NS 100 mL bag
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Lidocaine 1% - Sodium Bicarb 8.4% 10:1
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Lidocaine Buffered with J-Tip 0.25 mL
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Alteplase 1 mg/mL 1 mL in 10 mL syringe
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Oxytocin 30 units in NS 500 mL bag
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Norepinephrine 16 mg in NS 250 mL bag
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
NICARdipine 25 mg in NS 250 mL EXCEL bag
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Magnesium Sulfate 6 GM in NS 50 mL bag
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Magnesium Sulfate 4 GM in NS 50 mL bag
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Magnesium Sulfate 2 GM in NS 50 mL bag
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Magnesium Sulfate 1 GM in NS 50 mL bag
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Labetalol 20 mg/4 mL
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Diltiazem 250 mg in NS 250 mL bag
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Clindamycin 900 mg in NS 50 mL bag
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Dexmedetomidine 400 mcg in NS 100 mL bag
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Amoxicillin for Oral Suspension USP
Reason Subpotent Product: assay results for Amoxicillin were below the specification limits.
Class II · Moderate risk Terminated
Divalproex Sodium Extended-Release Tablets
Reason cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Class II · Moderate risk Terminated
GlipiZIDE Extended-release Tablets
Reason 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 Terminated
TriMix MEDIUM
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk Terminated
Trimix HIGH
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk Terminated
Test PROCYP
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.