The United States: Pharmedium Services, LLC expands voluntary nationwide recall of additional lots of compounded sterile products within expiry due to lack of sterility assurance (English Only)
 
The US Food and Drug Administration (FDA) announces that PharMEDium Services, LLC (PharMEDium) is voluntarily expanding the recall issued on 27 Dec 2017 to include all lots within expiry compounded at the Memphis, TN facility of sterile drug products to the hospital/user level due to a lack of assurance of sterility. 

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. Finished product release testing for both sterility and endotoxin were acceptable for all lots. Although there were no defects identified in these products, as a conservative measure, this recall is being expanded. 

These products were distributed nationwide in the USA to hospitals/clinics. A complete list of all recalled products can be found on pharmedium.com. http://www.pharmedium.com/company/news-and-events/) 

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, PharMEDium has not received any reports of adverse events related to the products but is issuing this recall out of an abundance of caution following a commitment made during a recent inspection of the company’s facility. 

Please refer to the following website in FDA for details: http://www.fda.gov/Safety/Recalls/ucm592096.htm 

In Hong Kong, there is no registered pharmaceutical product manufactured by the above company. Related news was previously issued by FDA, and was posted on the Drug Office website on 3 Jan 2018. 

Ends/Friday, Jan 12, 2018 
Issued at HKT 16:00 

 轉載自衛生署藥物辦公室網頁http://www.drugoffice.gov.hk/
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The United States: PharMEDium Services, LLC issues voluntary nationwide recall o... 上載於 2018-01-03