PharMEDium, headquartered in Lake Forest, Illinois. is a leading US provider of pharmacy-outsourced, ready-to-use compounded sterile preparations (CSPs) with over 20 years of experience. It operates four state-of-the-art, large-scale, 503B Outsourcing Facilities which are registered with the US Food and Drug Administration (FDA).
The company conducted a retrospective review of all commercially distributed product lots compounded in the Memphis location currently within its labeled expiration date in response to an FDA request, which led to the recall.
The FDA rrequest was in response to a microbial control programme during recent inspection to provide verification of acceptable microbiological testing results of the ISO Class 5 environment, personnel glove sampling results, media fill results, sterility testing results, and endotoxin results.
The review indicated that a total of 55 lots of different products impacting 25,327 units had two unsuccessful media fills. The remaining lots were associated with environmental monitoring or personnel monitoring excursions in the ISO 5 space on hood/surface and glove tip.
Finished product release testing for both sterility and endotoxin were acceptable. Although there were no defects identified in these products, as a conservative measure, a recall is being initiated.
The recalled products were distributed nationwide in the USA to hospitals and clinics. PharMEDium Services is notifying customers of the voluntary recall by phone. www.pharmedium.com.
The MedWatch Safety Alert, including a link to the press release, s available at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm591048.htm
