FDA Alert: Albuterol Sulfate Inhalation Solution, 0.083 percent (Nephron Pharmaceuticals): Recall – Aseptic Processing Simulation Results
ISSUE: Nephron Pharmaceuticals initiated a voluntary recall, at the retail level, of ten lots of product due to results from an internal monitoring process. NPC performs aseptic process simulation as part of an internal processes to assure product quality. All of the lots listed above met and passed NPC’s quality specifications at the time of manufacture. In accordance with published guidance regarding aseptic processing simulation from the FDA, NPC has initiated this recall as a precautionary measure.