Isomeric Pharmacy Solutions Issues Voluntary Nationwide Recall of All Sterile Compounded Products

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.

The sterile products were distributed to patients, providers, hospitals, or clinics nationwide between October 4, 2016 and February 7, 2017. The recall does not pertain to any non-sterile compounded medications prepared by Isomeric.

Isomeric is asking all patients and providers that received sterile compounded products from Isomeric between October 4, 2016 and February 7, 2017, and that remain within expiry, to take the following actions:

Discontinue use of the products;

Quarantine any unused product until further instructions are received on how to return the product; and

Contact Isomeric at (844) 470-2467 from the hours of 9:00 AM to 5:00 PM MDT Monday-Friday, or e-mail at recall@isomericrx.com to discuss the return of any unused sterile compounded products.

Isomeric is notifying its customers of the recall by mail and telephone or email and is arranging for a return of all recalled products that remain unused.  Customers with questions regarding this recall can contact Isomeric at (844) 470-2467 from the hours of 9:00 AM to 5:00 PM MDT Monday-Friday, or e-mail at recall@isomericrx.com to discuss the return of any unused sterile compounded products.  Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.  Providers who have dispensed any sterile product distributed by Isomeric to a patient(s) for use out of the provider’s office should contact the patient(s) to whom product was dispensed and advise the patient(s) of this recall.

This recall is being conducted with the knowledge of and at the request of the U.S. Food and Drug Administration.