Washington, D.C. (FDA) — Nephron Pharmaceuticals Corporation (NPC) has initiated a voluntary recall, at the retail level, as a precautionary measure, due to results from our internal monitoring processes. NPC is asking retailers to remove the affected lots from store shelves and is asking consumers to discontinue use and dispose of any product they may have that is included in this recall. This voluntary recall will affect the following product:
Albuterol Sulfate Inhalation Solution, 0.083%, in the 25 count packaging configuration (NDC# 0487-9501-25)
Ten (10) lots have been identified as impacted by this recall:
A3A33A, A3A33B, A3A34A, A3A35A, A3A36A, A3A37A, A3A38A, A3A40A, A3A41A, and A3A42A
NPC performs aseptic process simulation as part of our internal processes to assure product quality. All of the lots listed above met and passed NPC’s quality specifications at the time of manufacture. NPC has received no reportable adverse drug events for any of the lots included in this recall. Nevertheless, in accordance with published guidance regarding aseptic processing simulation from the Food and Drug Administration (FDA), NPC has decided to initiate this recall as a precautionary measure.
No other NPC products or lots are impacted by this recall.
We are ready to work with every affected customer to ensure that the recall is not disruptive for the supply of this important drug product.