- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Reason for Announcement:
Recall Reason DescriptionDue to Lack of Sterility Assurance
- Company Name:
- Isomeric Pharmacy Solutions
- Brand Name:
Brand Name(s)Isomeric Pharmacy Solutions
- Product Description:
Product DescriptionMultiple compounded sterile products
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.
The sterile products were distributed to patients, providers, hospitals, or clinics nationwide between October 4, 2016 and February 7, 2017. A list of all drugs affected by this recall is available here: https://www.isomericrx.com/news/april-2017-recall-information/april-2017-recall-log-list/. 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 email@example.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 firstname.lastname@example.org 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.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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
This recall is being conducted with the knowledge of and at the request of the U.S. Food and Drug Administration.
Isomeric’s primary concern is your safety and Isomeric is taking this action out of an abundance of caution. Thank you for your support.