Lemmon Co.'s injectable diazepam labeling

Executive Summary

Company said that validation work on its labeling process for diazepam syringes will be completed in "the next day or so." FDA is currently conducting a GMP inspection at Lemmon, which follows a recall in June involving 44,470 diazepam syringes. A number of the syringes lacked immediate container labels ("The Pink Sheet" July 3, T&G-17). In December, a recall was initiated for the same reason. According to an Aug. 8 FDA reg letter, Lemmon made corrections to prevent a recurrence of unlabeled syringes after the first recall. However, FDA said that it will not approve drug applications until it is determined through reinspection that "adequate corrective action has been taken".