Thursday, 17 October 2013

Media fill failure triggers product recall


Nephron Pharmaceuticals Corporation (NPC) has initiated a voluntary recall, at the retail level. This is due to a failure to pass a media fill (aseptic process simulation trial). The statement reads:

"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. "

NPC has asked 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 relates to the following product: Albuterol Sulfate Inhalation Solution, 0.083%, in the 25 count packaging configuration (NDC# 0487-9501-25).

Posted by Tim Sandle