454 recalls, newest first
Reason CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Reason Failed tablet specifications.
Reason Crystallization; identified as Buprenorphine free base
Reason Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Reason Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Chemical contamination: Presence of benzene
Reason Chemical contamination: Presence of benzene
Reason Chemical contamination: Presence of benzene