Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
Rosuvastatin Tablets
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Ongoing
Rosuvastatin Tablets
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Ongoing
Montelukast Sodium Tablets
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Ongoing
Glimepiride Tablets
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Ongoing
Finasteride Tablets
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Ongoing
Doxazosin Tablets
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Ongoing
Doxazosin Tablets
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Ongoing
Clopidogrel Tablets USP
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Ongoing
Alprazolam C-IV
Reason CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Class II · Moderate risk Ongoing
Alprazolam C-IV
Reason CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Class II · Moderate risk Ongoing
Alprazolam C-IV
Reason CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Class II · Moderate risk Ongoing
Aripiprazole Tablets
Reason Out of specification (OOS) for Spectroscopic Identification test by IR.
Class II · Moderate risk Ongoing
Tadalafil Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Tadalafil Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Glimepiride Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Glimepiride Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Doxazosin Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
BusPIRone Hydrochloride Tablets USP
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets
Reason CGMP Deviations
Class III · Low risk Ongoing
Epinephrine Professional EMS
Reason Labeling; Incorrect NDC number on outer carton of product.
Class II · Moderate risk Ongoing
Dabigatran Etexilate 150mg Capsules
Reason CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Class II · Moderate risk Ongoing
Dabigatran Etexilate Capsules
Reason CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.