PharMEDium Services Expands Recall

PharMEDium Services is expanding the recall issued on December 27, 2017 to include additional sterile drug products due to a lack of assurance of sterility.  Administration of a drug products intended to be sterile that is not sterile could result in serious infections that may be life-threatening. 

The recall is being expanded because PharMEDium conducted  an extensive review of all commercially distributed product lots compounded in the Memphis location currently within their labeled expiration date in response to an FDA request regarding microbial program controls for the ISO5 environment, personnel glove sampling results, media fill results, sterility testing results, and endotoxin results following the most recent inspection.  The original recall included a total of 55 lots of different products impacting 25,327 units.  The expanded recall includes all lots within expiry compounded at the Memphis, TN facility.

Although there were no defects identified in these products, as a conservative measure, this recall is being expanded.

A complete list of all recalled products can be found on pharmedium.com.