18,003 recalls, newest first
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.
Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.
Crystallization; Complaints that cream appears to have crystallized
Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
Labeling: Incorrect or Missing Package Insert
Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.
Failed Dissolution Specifications
Failed Impurities/Degradation Specification; 9 month stability
Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
Failed Tablet/Capsule Specifications
cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.