18,003 recalls, newest first
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Subpotent Drug: Out of specification for assay
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Out of specification for related substances (impurities).
Lack of Assurance of Sterility: environmental monitoring failure.
Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Presence of Particulate Matter: Piece of metal found in a vial
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
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).
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity