Advocacy & Practice Updates — Advocacy & Practice
FDA Alert: Martin Avenue Pharmacy Recalls Compounded Sterile Preparations
Recall prompted by lack of sterility assurance
The US Food and Drug Administration (FDA) has announced that Martin Avenue Pharmacy, Inc (Naperville, IL) has initiated a voluntary recall of all in-date compounded sterile preparations.
The pharmacy states that the recall is in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
According to the FDA, Martin Avenue Pharmacy supplied compounded sterile preparations to the offices of licensed medical professionals and individual patients by prescription until August 20, 2014 in multiple states including Illinois, Wisconsin, Ohio, Michigan, Florida, Alabama, and Texas.
If you or your patients have any of the recalled products, you are advised to stop using them and follow the instructions in the recall notice. Martin Avenue Pharmacy is notifying its customers of this recall by fax, mail, phone, or email with instructions on how to return recalled compounded sterile preparations to the pharmacy.
If you have any questions about the recall, please call Martin Avenue Pharmacy at 630-355-6400 or toll free at 888-355-6492, Monday through Friday between 9:00 AM and 7:00 PM Central Time, or email firstname.lastname@example.org.
To report an adverse event or side effect:
- Download the form or call 800-332-1088 to request the reporting form. Complete and return it to the address on the form, or fax to 800-FDA-0178.
Updated September 2, 2014