Main Street Family Pharmacy, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Products

Date of Recall

2013-05-28

Recall Details

- May 28, 2013 - Newbern, Tennessee--Main Street Family Pharmacy, LLC today announced a voluntary nationwide recall of all lots of all sterile products compounded by the pharmacy. The compounded products that are subject to the recall are those products with a use by date on or before November 20, 2013. The recall is being initiated due to seven (7) reported cases of adverse events in the form of skin abscesses, one of which appears to be fungal in nature. An investigation into the exact source of the adverse events is still ongoing. This announcement updates a press release that was issued by the FDA on May 24, 2013.

Patients are at increased risk for serious infections in the event a sterile product is compromised. To date Main Street Family Pharmacy, LLC has only received reports of adverse events in three (3) lots of preservative-free methylprednisolone acetate (MPA). At this time, there have been no additional reports of injury or illness associated with the use of our sterile compounded products. Patient safety is our highest priority and, out of an abundance of caution, we have decided to initiate this voluntary recall to include all sterile products. The product list is attached.

These products were supplied to the offices of licensed medical professionals and patients. Sterile products included in this withdrawal were distributed nationwide. Main Street Family Pharmacy, LLC will be notifying customers by phone, fax, email, and/or mail to return the products to the pharmacy. The sterile products include all injectables with the Main Street Family Pharmacy name.

Consumers or Health Care providers with questions regarding this recall may contact Main Street Family Pharmacy, LLC by phone at 731-627-2221 or 888-658-6200 from the hours of 8:30AM-6:00PM Central Standard Time Monday-Friday or email address at [email protected]. Patients who have received any sterile compounded product supplied by Main Street Family Pharmacy, LLC and have concerns should contact their healthcare provider.

Adverse reactions or quality problems experienced with the use of sterile compounded products from Main Street Family Pharmacy, LLC may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or fax.

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

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

PRODUCT RECALL LIST

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