17,898 recalls, newest first
Reason Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Reason Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Reason Subpotent Drug: Out of specification for assay
Reason cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Reason Out of specification for related substances (impurities).
Reason Lack of Assurance of Sterility: environmental monitoring failure.
Reason Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
Reason Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Reason Presence of Particulate Matter: Piece of metal found in a vial
Reason Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Reason Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Reason Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Reason Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Reason Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
Reason Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Reason Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Reason CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Reason Lack of Assurance of Sterility
Reason Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Reason Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Reason Chemical Contamination: product found to contain benzene
Reason GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.