Albuterol Sulfate Inhalation Solution, 0.083%, in the 25 count packaging configuration (NDC# 0487-9501-25) has been recalled due to results from the manufacturer’s internal monitoring processes. Nephron Pharmaceuticals Corporation (NPC) asked retailers to remove the affected lots from store shelves and consumers to discontinue use and dispose of any product they may have.
Often used in asthma treatment, Albuterol is a bronchodilator that relaxes muscles in the airways and increases air flow to the lungs. Albuterol inhalation is used to treat or prevent bronchospasm in people with reversible obstructive airway disease. Albuterol is also used to prevent exercise-induced bronchospasm.
NPC performed aseptic process simulation as part of its internal processes to assure product quality. In accordance with published FDA guidance regarding aseptic processing simulation results, NPC initiated this recall.
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication