Class II · Moderate risk Ongoing
fentaNYL Citrate PF 200 mcg/100 mL
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
fentaNYL Citrate PF 200 mcg/100 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
fentaNYL Citrate PF 200 mcg/100 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual…
Reason cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
Class II · Moderate risk Ongoing
La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System
Reason cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
Class II · Moderate risk Ongoing
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual…
Reason Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.
Class II · Moderate risk Ongoing
Testosterone Gel 1%
Reason Presence of foreign substance: Presence of Benzene.
Class II · Moderate risk Ongoing
Testosterone Gel 1%
Reason Presence of foreign substance: Presence of Benzene.
Class II · Moderate risk Ongoing
Prasugrel Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
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.
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 II · Moderate risk Ongoing
Zapzyt
Reason Chemical Contamination: Presence of benzene.
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