Class II · Moderate risk
Testosterone Gel 1%
Presence of foreign substance: Presence of Benzene.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Prasugrel Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class III · Low risk
Gabapentin Capsules
Cross Contamination
Class III · Low risk
Gabapentin Capsules
Cross Contamination
Class III · Low risk
Tolterodine Tartrate Extended-Release Capsules
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Class II · Moderate risk
Unisom
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Class II · Moderate risk
Carvedilol Tablets USP 25 mg
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · Moderate risk
Carvedilol Tablets USP 12.5 mg
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · Moderate risk
Carvedilol Tablets USP 6.25 mg
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · Moderate risk
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · Moderate risk
Walgreens
Chemical Contamination: Presence of benzene
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · Moderate risk
Neupogen (filgrastim)
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
Neupogen (filgrastim)
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
Metformin Hydrochloride Extended- Release 500mg
Presence of Foreign Tablets/Capsules.
Class II · Moderate risk
Prasugrel Tablets
Failed Dissolution Specifications - low dissolution results
Class III · Low risk
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution
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
Zapzyt
Chemical Contamination: Presence of benzene.
Class III · Low risk
Livalo (pitavatstatin)
Presence of foreign tablets/capsules
Class I · High risk
Vitality
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Class I · High risk
PHENYLephrine added to 0.9% sodium chloride
Presence of Particulate Matter
Class II · Moderate risk
Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe
Lack of Assurance of Sterility: due to a quality control process deviation