Class II · Moderate risk Terminated
Magnesium Sulfate 2 GM in NS 50 mL bag
Reason Lack of sterility assurance.
FDA Drug Recalls
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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 III · Low risk Terminated
Morphine Sulfate Extended-Release Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Morphine Sulfate Extended-Release Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Morphine Sulfate Extended-Release Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Morphine Sulfate Extended-Release Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Morphine Sulfate Extended-Release Tablets
Reason Failed Impurities/Degradation Specifications
Class I · High risk Terminated
Aphrodisiac Platinum 40000
Reason Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sildenafil
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.
Class II · Moderate risk Terminated
Test D
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk Terminated
Test D
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk Terminated
Lipoplex
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk Terminated
HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL…
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
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.
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.