Class II · Moderate risk Ongoing
Unisom
Reason CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
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Class II · Moderate risk Ongoing
Carvedilol Tablets USP 25 mg
Reason CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · Moderate risk Ongoing
Carvedilol Tablets USP 12.5 mg
Reason CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · Moderate risk Ongoing
Carvedilol Tablets USP 6.25 mg
Reason CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · Moderate risk Ongoing
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle
Reason CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · Moderate risk Ongoing
Walgreens
Reason Chemical Contamination: Presence of benzene
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Neupogen
Reason Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Class II · Moderate risk Ongoing
Neupogen
Reason Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Class II · Moderate risk Ongoing
Metformin Hydrochloride Extended- Release 500mg
Reason Presence of Foreign Tablets/Capsules.
Class II · Moderate risk Ongoing
Prasugrel Tablets
Reason Failed Dissolution Specifications - low dissolution results
Class III · Low risk Ongoing
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile…
Reason Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Class II · Moderate risk Ongoing
Zapzyt
Reason Chemical Contamination: Presence of benzene.
Class III · Low risk Completed
Livalo
Reason Presence of foreign tablets/capsules
Class I · High risk Ongoing
Vitality
Reason Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Class I · High risk Ongoing
PHENYLephrine added to 0.9% sodium chloride
Reason Presence of Particulate Matter
Class II · Moderate risk Completed
Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe
Reason Lack of Assurance of Sterility: due to a quality control process deviation
Class II · Moderate risk Ongoing
CURAD Alcohol Prep Pads
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Medline Alcohol Prep Pads
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II · Moderate risk Ongoing
Lorazepam 0.5 mg per 0.25 mL Oral Syringe
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II · Moderate risk Ongoing
Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II · Moderate risk Ongoing
Simethicone 20 mg per 0.3 mL Oral Syringe
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.