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August 15, 2017 Press Release

Isomeric is a registered with FDA as a Section 503B sterile compounder. Since voluntarily registering with FDA, Isomeric has endeavored to work closely with the agency on meeting FDA’s cGMP expectations.  However, FDA’s expectations for Section 503B compounders are unclear; FDA is still in the process of developing these cGMP requirements.  FDA has not yet proposed, let alone promulgated, regulations setting the specific cGMP requirements for outsourcing facilities…

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April 2017 Recall Information

FOR IMMEDIATE RELEASE–April 7, 2017–Salt Lake City, Utah; Isomeric Pharmacy Solutions (“Isomeric”) is voluntarily recalling all lots of sterile products compounded and packaged by Isomeric and that remain within expiry to the hospital/user level because of the US Food and Drug Administration’s concerns of a lack of sterility assurance. These concerns were brought to Isomeric’s attention during a recent inspection by the US Food and Drug Administration.  To date, Isomeric has not received any reports of adverse events related to this recall…

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