Class III · Low risk Terminated
Ceftriaxone for Injection USP
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
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Class III · Low risk Terminated
Ceftriaxone for Injection USP
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk Terminated
Ceftriaxone for Injection USP
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk Terminated
Ceftriaxone for Injection USP
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk Terminated
Sodium Iodide I 131 Capsule
Reason Labeling: Label Error on Declared Strength
Class I · High risk Terminated
Amikacin Sulfate injection USP
Reason Presence of Particulate Matter: particulate matter identified as glass in one vial.
Class II · Moderate risk Terminated
Potassium Chloride Injection 20 mEq
Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk Terminated
Mannitol I.V.
Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk Terminated
Aminosyn-PF
Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk Terminated
Dextrose Injection
Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk Terminated
Dextrose Injection
Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk Terminated
Dextrose Injection
Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk Terminated
Zoledronic Acid Injection
Reason Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Class II · Moderate risk Terminated
Fluconazole Injection
Reason Cross contamination with other products: metronidazole
Class III · Low risk Terminated
col-rite
Reason Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
Class III · Low risk Terminated
Telmisartan Tablets
Reason Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
Class III · Low risk Terminated
Amlodipine Besylate Tablets USP
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk Terminated
Amlodipine Besylate Tablets USP
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class II · Moderate risk Terminated
Thyrogen
Reason Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Class II · Moderate risk Terminated
Thyrogen
Reason Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Class II · Moderate risk Terminated
Paliperidone Extended-release Tablets
Reason Failed Dissolution Specifications; three month stability time point.