PHARMACEUTICAL FIRM RECALLS NASAL SPRAY FOR POTENTIAL MICROBIAL CONTAMINATION (10/02/13)

NEPHRON PHARMACEUTICALS APPLAUDED FOR PROACTIVE STANCE

Nephron Pharmaceuticals Corporation, Orlando, FL (NPC) recalled 689,568 cartons (ten lots) of Albuterol Sulfate Inhalation Solution for oral inhalation.  The recall, which was initiated by the firm and was voluntary, was caused by a “Lack of Assurance of Sterility:  Nephron Pharmaceutical Corporation conducted a routine simulation and discovered bacterial growth in a number of media vials, exceeding the acceptable limit”.

“All of the lots (noted) 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.”

FDA Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice, September 2004 recommends that “at least three consecutive separate successful runs be performed during initial line qualification.     Subsequently, routine semi-annual qualification conducted for each processing line will evaluate the state of control of the aseptic process”.

Because NPC indicated that the recall was caused by a “lack of assurance of sterility”, and that it occurred during a routine simulation, it is assumed that the growth occurred within a semi-annual qualification.  The FDA currently allows a total of one failure per five thousand vials and two failures per 10,000 vials.  Because NPC used the term “number of media vials”, it can only be assumed that the numbers of positive vials observed within this media fill exceeded those numbers recommended by the FDA.  Because NPC reacted proactively to their findings, they should be applauded for their efforts.

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