Tuesday, October 22, 2013

Albuterol Sulfate Inhalation Solution, 0.083 percent (Nephron Pharmaceuticals): Recall

It's been a busy few days for the FDA  post-shutdown:

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.

BACKGROUND: The affected product is identified as Albuterol Sulfate Inhalation Solution, 0.083%, in the 25 count packaging configuration (NDC# 0487-9501-25) and lots A3A33A, A3A33B, A3A34A, A3A35A, A3A36A, A3A37A, A3A38A, A3A40A, A3A41A, and A3A42A.