Class II · Moderate risk Ongoing
Curosurf
Reason Lack of Assurance of Sterility
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
Cinacalcet Hydrochloride Tablets
Reason CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Class II · Moderate risk Ongoing
Cinacalcet Hydrochloride Tablets
Reason CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Class II · Moderate risk Ongoing
Cinacalcet Hydrochloride Tablets
Reason CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Class II · Moderate risk Ongoing
Meclizine Hydrochloride Tablets
Reason Failed tablet specifications.
Class II · Moderate risk Ongoing
Buprenorphine Hydrochloride
Reason Crystallization; identified as Buprenorphine free base
Class II · Moderate risk Ongoing
Lanreotide Injection
Reason Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Class II · Moderate risk Ongoing
Lanreotide Injection
Reason Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Class II · Moderate risk Ongoing
5% Dextrose Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
5% Dextrose Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
5% Dextrose Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.45% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Icosapent Ethyl Capsules
Reason Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Class II · Moderate risk Ongoing
Semaglutide-Glycine-Cyanocobalamin Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*
Reason Lack of Assurance of Sterility