Martin Avenue Pharmacy, Inc. Issues a Voluntary Multi-State Recall of All Compounded Sterile Preparations Due to a Lack of Assurance of Sterility

Date of Recall

2014-09-02

Recall Details

- August 27, 2014 - Naperville, Illinois, 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. To date, Martin Avenue Pharmacy, Inc. has received no reports of suspected infection or other injury, illness or complaints associated with the use of its compounded sterile preparations. However, in an abundance of caution, and in the interest of patient safety, Martin Avenue Pharmacy, Inc. has proactively decided to voluntarily proceed with this recall process and to cease production of compounded sterile preparations until further notice. Martin Avenue Pharmacy, Inc. is committed to compounding quality and patient safety.

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.

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. Patients and healthcare providers that have product which is being recalled should stop using the products, and follow the instructions in the recall notice. To identify which sterile products and lots are being recalled, visit http://www.martinavenue.com/voluntaryrecall/.

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 at [email protected]. Be advised, this recall does not pertain to any non-sterile compounded medications prepared by the pharmacy.

Adverse reactions or quality problems experienced with the use of any of the recalled compounded sterile preparations may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:
  www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

Martin Avenue Pharmacy's management and pharmacists deeply regret the disruption that the voluntary recall and temporary suspension of its sterile compounding service may have on pharmacy's patients, but emphasize that patient safety is always its first concern.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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