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RECALL: PharMEDium Products Recalled Due to Lack of Assurance of Sterility
PharMEDium has expanded a previous recall due to the lack of assurance of sterility of various products compounded at the company’s Memphis, Tennessee, facility.
Administration of a drug product intended to be sterile that is not sterile could result in serious or life-threatening infections. This potential has led PharMEDium Services, LLC to recall several lots of sterile drug products.
After conducting an extensive review of commercially distributed products compounded at its Memphis, Tennessee, facility and currently within their labeled expiration, the company is expanding its original recall, which included 55 lots impacting 25,327 individual units, due to the lack of assurance of sterility at the location.
PharMEDium conducted the retrospective review 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. Although no product defects were detected, the recall is be expanded as a conservative measure.
Specific lots of fentanyl, midazolam, morphine, adenosine, and many other drugs are being recalled. All affected lot numbers can be found on the PharMEDium website.
PharMEDium has not received any reports of adverse events, but is still notifying customers of the recall by phone and email.
If you have purchased any of the affected products, the company asks that you discontinue use, quarantine the product, and destroy it per your hospital protocol. Questions should be directed to a PharMEDium Services Clinical Pharmacist at 800-523-7748 or at recall17023@pharmedium.com.