Recall: PharMEDium Services LLC Various Compounded Drug Products Intended To Be Sterile
On 2018-01-11, the FDA announced that PharMEDium Services is conducting a recall on Various Compounded Drug Products Intended To Be Sterile due to a possible lack of sterility. The recalled products were sold under the brand name(s) PharMEDium Services LLC during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 3 drugs recalls due to potential lack of sterility, including compounded injectables, injectable drugs and more. Additionally, there have been 11 drug and medical device recalls due to other health hazards as well as 121 food recalls.
Company Contact Information:
Name: PharMEDium Services
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Detailed Recall Information
Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.
Product Description: Various compounded drug products intended to be sterile
Brand Name(s): PharMEDium Services LLC
Reason for Recall: Lack of sterility assurance
Official Recall Date: 2018-01-11
Additional information provided by the FDA.gov:
PharMEDium Services, LLC (PharMEDium) is voluntarily expanding the recall issued on December 27, 2017 to include the below lots of sterile drug products to the hospital/user level due to a lack of assurance of sterility. 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. Read More.
More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.