Martin Avenue Pharmacy Inc. of Naperville, Ill. is conducting a voluntary recall of all in-date compounded sterile preparations. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance. If the sterility of a compounded preparation is compromised, a patient is at risk for infection.
Martin Avenue Pharmacy Inc. supplied compounded sterile preparations to the offices of licensed medical professionals and individual patients by prescription until 08/20/14 in multiple states including IL, WI, OH, MI, FL, AL, and TX.
Patients and healthcare providers that have product which is being recalled should stop using the products, and follow the instructions in the recall notice. Martin Avenue Pharmacy Inc. is notifying its customers of this recall by fax, mail, phone, or email with instruction on how to return recalled compounded sterile preparations to the pharmacy.
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.
Release Date: September 2, 2014