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.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm371210.htm
