FDA inspection triggers recall by St. Petersburg pharmacy

10:24 PM, May 8, 2013   |    comments
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ST. PETERSBURG, Florida - The Food and Drug Administration is warning doctors and pharmacists to avoid drugs made by a Florida specialty pharmacy called The Compounding Shop, due to potential safety problems uncovered by health inspectors.

The Compounding Shop is a compounding pharmacy, which means it mixes custom formulations of drugs to meet doctor's specifications.

According to an inspection on April 18-22, the FDA observed poor sterile production practices that could have caused drugs being made at its facilities near the corner of Park St N. & 40th Ave N. to be "life-threatening."

Despite the findings by the FDA, at least one long-time customer has her doubts. "I've know them and I know that they do a good job. And I've never heard anyone say anything about this place," said Patti Adams, who told us she has shopped at the company for 15 years.

In the inspection report, among the drugs made at The Compounding Shop is Dexamethasone, used to treat allergies, Morphine, which treats pain, and Avastin, which treats cancers.

10 News reached out to the company and the FDA, however, neither has released any new information about the dates of sale or the drugs beyond what is listed in the inspection report.

The company is reportedly recalling sterile products and is in the process of notifying customers.

"If an injectable drug product that is intended to be sterile is contaminated, it could result in a life-threatening infection in patients," said Janet Woodcock, M.D., director, FDA's Center for Drug Evaluation and Research. "We do not have reports of patient infections. 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."

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