Class II · Moderate risk Ongoing
Albuterol Sulfate Inhalation Solution
Reason Labelling: Illegible label
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Xanax XR
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Octreotide Acetate for Injectable Suspension
Reason Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk Ongoing
Octreotide Acetate for Injectable Suspension
Reason Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk Ongoing
Octreotide Acetate for Injectable Suspension
Reason Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk Ongoing
Curosurf
Reason Lack of Assurance of Sterility
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