Prescription and over-the-counter medications
THE COMPOUNDING SHOP
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
THE COMPOUNDING SHOP
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
THE COMPOUNDING SHOP
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
THE COMPOUNDING SHOP
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Novartis Consumer Health
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
THE COMPOUNDING SHOP
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
THE COMPOUNDING SHOP
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
THE COMPOUNDING SHOP
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
THE COMPOUNDING SHOP
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Teva Pharmaceuticals USA
CGMP Deviation; cotton coil is missing in some packaged bottles
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.