FDA MedWatch - Sterile Compounded Products by Isomeric Pharmacy Solutions: Recall - Lack of Sterility Assurance

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Sterile Compounded Products by Isomeric Pharmacy Solutions: Recall - Lack of Sterility Assurance

AUDIENCE: Patient, Pharmacy

ISSUE: 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 FDA concerns of a lack of sterility assurance. These concerns were brought to Isomeric’s attention during a recent FDA inspection.

The sterile products were distributed to patients, providers, hospitals, or clinics nationwide between October 4, 2016 and February 7, 2017. See the press release for a link to list of all drugs affected by this recall.

BACKGROUND: To date, Isomeric has not received any reports of adverse events related to this recall. This recall does not pertain to any non-sterile compounded medications prepared by Isomeric.

RECOMMENDATION: 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 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.

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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the press release, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm551299.htm