Class II · Moderate risk Terminated
Rifampin Capsules
Reason Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
FDA Drug Recalls
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Class II · Moderate risk Terminated
Rifampin Capsules
Reason Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Class II · Moderate risk Completed
Quinapril and Hydrochlorothiazide Tablets
Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class I · High risk Terminated
8.4% Sodium Bicarbonate Injection
Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Class I · High risk Terminated
8.4% Sodium Bicarbonate Injection
Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Class II · Moderate risk Terminated
Fondaparinux Sodium Injection
Reason Subpotent Drug: Out of specification for assay
Class II · Moderate risk Terminated
Pyridostigmine Bromide Oral Solution
Reason cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Class II · Moderate risk Completed
Flunisolide Nasal Solution
Reason Out of specification for related substances (impurities).
Class II · Moderate risk Terminated
Arformoterol Tartrate Inhalation Solution
Reason Lack of Assurance of Sterility: environmental monitoring failure.
Class I · High risk Terminated
Atenolol Tablets
Reason Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
Class II · Moderate risk Terminated
Aminophylline Injection
Reason Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Class III · Low risk Ongoing
Tranexamic Acid Injection
Reason Presence of Particulate Matter: Piece of metal found in a vial
Class II · Moderate risk Completed
Acyclovir Sodium Injection
Reason Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class II · Moderate risk Ongoing
Rifampin Capsules
Reason Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Class II · Moderate risk Ongoing
Rifampin Capsules
Reason Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Class II · Moderate risk Terminated
Ampicillin for Injection
Reason Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Class III · Low risk Terminated
oxyTOCIN 30 Units/500 mL
Reason Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
Class III · Low risk Terminated
Clonidine Hydrochloride Tablets
Reason Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Class III · Low risk Terminated
Xolegel
Reason Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Class II · Moderate risk Terminated
Neoral soft gelatin capsules
Reason CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Class II · Moderate risk Terminated
Budesonide Inhalation Suspension 0.25mg/2mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lisinopril 10 mg tablets
Reason Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class III · Low risk Completed
Phytonadione Injectable Emulsion USP
Reason Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Class I · High risk Terminated
Antica Farmacista Hand Sanitizer Ocean Citron
Reason Chemical Contamination: product found to contain benzene
Class II · Moderate risk Terminated
Sanitizing Hand Spray 80%
Reason GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.