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ISSUE: MAY 2013 | VOLUME: 40
FDA Urges Recall of Sterile Drug Products from Florida Compounder
by PPN Staff
The FDA announced that it has “concerns about a lack of sterility assurance for sterile drugs” distributed by The Compounding Shop of St. Petersburg, Fla. Based on those concerns, sterile drugs distributed by the company “should not be administered to patients,” the agency noted in a statement.
Janet Woodcock, MD, the director of FDA’s Center for Drug Evaluation and Research, stressed the potential dangers posed by tainted products. “If an injectable drug product that is intended to be sterile is contaminated, it could result in a life-threatening infection,” Dr. Woodcock said.
The FDA noted that no such infections have been reported in patients treated with drugs shipped by The Compounding Shop. “However, due to concerns about a lack of sterility assurance at the facility and out of an abundance of caution, we have advised the firm to remove its sterile products from the market to protect patients.”
The Compounding Shop is complying with the recall and the firm is in the process of notifying customers, according to the FDA. In the meantime, “health care providers and hospital staff should immediately check their medical supplies, quarantine any sterile products from The Compounding Shop, not administer them to patients and await further instructions from the company regarding the recalled products.”
These actions were prompted by a recent inspection of The Compounding Shop, during which FDA investigators “observed poor sterile production practices.” The agency has not released any further details on the extent or type of sterility problems encountered.
A Litany of Problems
The Compounding Shop's problems with sterility compliance are not an isolated occurence; several earlier FDA inspections of compounding facilities have led to large-scale sterile product recalls. For example, on April 17, Balanced Solutions Compounding Pharmacy, of Lake Mary, Fla., recalled its sterile products after FDA inspectors found evidence of gram-negative bacteria in samples of the firm's chromium chloride preparation for injection. And on March 20, Clinical Specialties, of Augusta, Ga., recalled all of its sterile products due a lack of sterility assurance.