Main Street Family Pharmacy recalls all sterile products after reports of seven skin abscess cases

Newbern, Tennessee compounding pharmacy, Main Street Family Pharmacy, announce a voluntary recall of all of it’s sterile products on Tuesday.

Main Street Family Pharmacy
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The recall comes on the heels of a Food and Drug Administration (FDA) report of seven adverse events in the form of skin abscesses, with at least one case confirmed as caused by a fungus. The adverse events are linked to three (3) lots of preservative-free methylprednisolone acetate (MPA).

Main Street Family Pharmacy says the compounded products that are subject to the recall are those products with a use by date on or before November 20, 2013. See the recall notice to see the entire list of affected products.

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.

According to the Tennessee Department of Health, staff members at Main Street Family Street Pharmacy in Newbern, Tenn., have been fully cooperative with Tennessee Board of Pharmacy investigators. Board investigators have confirmed a well-constructed, clean facility and are continuing to review all aspects of the compounding process.

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

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