Isomeric Pharmacy Solutions is recalling all lots of sterile products compounded and packaged by the company that remain within the expiration date after a Food and Drug Administration (FDA) inspection raised concerns about the lack of sterility of the products. To date, there have been no reports of adverse events related to this recall.
Affected products were distributed to patients, providers, hospitals and clinics nationwide between Oct. 4, 2016, and Feb. 7, 2017. A list of drugs affected by this recall is available here. Non-sterile compounded medications prepared by Isomeric are not subject to the recall.
Patients and providers that received sterile compounded products from Isomeric between Oct. 4, 2016 and February 7, 2017, that remain within the expiration date, should discontinue use, and quarantine any unused products until further instructions are received regarding return of the product. Consumers and customers with questions can contact Isomeric at (844) 470-2467 from 9 a.m. to 5 p.m. MDT Monday-Friday, or email the company at firstname.lastname@example.org.
Isomeric is notifying customers by mail and telephone or email, and is arranging for a return of all recalled products that remain unused. Consumers who have experienced any side effects that may be related to taking or using these drug products should contact their healthcare provider. Any adverse events related to this recall should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recalls