PharMEDium Services recalls some compounded sterile products due to lack of sterility assurance
PharMEDium Services has issued a voluntary recall of certain lots of compounded sterile drug products due to a lack of sterility assurance.
PharMEDium Services has issued a voluntary recall of certain lots of compounded sterile drug products due to a lack of sterility assurance. The recall follows a retrospective review of all commercially distributed product lots compounded in the Memphis location currently within their labeled expiration data in response to an FDA request regarding a microbial control program during a recent inspection to provide verification of acceptable microbiological testing results of the ISO5 environment, personnel glove sampling results, media fill results, sterility testing results, and endotoxin results. According to the review, 55 lots of different products affecting more than 25,000 units had two unsuccessful media fills. The rest of the 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. There were no defects identified in the products; however, the recall was issued as precaution. The affected products were distributed nationwide to hospitals and clinics. A full list of the recalled products is available here.