September 03, 2014
FDA MedWatch - Martin Avenue Pharmacy, Inc. Compounded Sterile Preparations: Recall - Lack of Assurance of Sterility
AUDIENCE: Pharmacy, Patient
ISSUE: Martin Avenue Pharmacy, Inc. 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.
BACKGROUND: 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.
RECOMMENDATION: 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.
Consumers or health care providers with questions regarding this recall may contact Martin Avenue Pharmacy, Inc. by phone at (630) 355-6400 or toll free (888) 355-6492, Monday through Friday, 9:00 a.m. to 7:00 p.m. Central Time or by e-mail firstname.lastname@example.org.
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.htm
• 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 links to the Firm Press Release: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm412493.htm