💊 Drugs • 12,141 recalls
Pharmacy Plus, Inc.
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.
Pharmacy Plus, Inc.
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.
Subpotent Drug: Out of specification for assay
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Golden State Medical Supply
Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
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
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Golden State Medical Supply
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Ingenus Pharmaceuticals
Out of specification for related substances (impurities).
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Fresenius Medical Care Holdings
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Presence of Particulate Matter: Piece of metal found in a vial
Lack of Assurance of Sterility: environmental monitoring failure.
Dr. Reddy's Laboratories
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
SUN PHARMACEUTICAL INDUSTRIES
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
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).