THE COMPOUNDING SHOP Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The recall — FDA D-555-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Complete FDA and NHTSA recall records dated in 2013, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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.
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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.
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.
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.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
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.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
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.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.