ST. PETERSBURG — A local compounding pharmacy has agreed to recall all its sterile drugs after a recent inspection uncovered potential safety problems, the U.S. Food and Drug Administration said Wednesday.
Federal health inspectors discovered "exposed rust" and "numerous splattered brownish stains" on equipment used to prepare injectable drugs and eye medications at the Compounding Shop, raising the possibility that the medications could be contaminated.
The FDA on Wednesday said it had urged the Compounding Shop to take the action as a precaution, though the agency noted the St. Petersburg pharmacy is not implicated in any reports of illness.
The Compounding Shop, which declined to comment Wednesday, was one of more than 30 facilities that the FDA inspected earlier this year. The St. Petersburg pharmacy is one of a handful of those facilities that have recalled medications.
The FDA's crackdown came after last year's national outbreak of fungal meningitis, which was linked to tainted drugs made by Massachusetts-based New England Compounding Center. Fifty-three people, including five in Florida, died in that outbreak, and hundreds were sickened.
The Compounding Shop is in the process of notifying customers, federal officials say.
"If an injectable drug product that is intended to be sterile is contaminated, it could result in a life-threatening infection in patients," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement. "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."
Compounding pharmacies have long customized drugs for patients with special needs, like a liquid form of a medicine for someone who cannot swallow a pill. But in recent years, as their numbers multiplied, some have become essentially mass manufacturers. The FDA says it has limited authority to oversee their operations, which are regulated by state boards of pharmacy.
Inspectors also found problems at a Tampa compounding pharmacy, AnazaoHealth Corp., but that facility has not recalled drugs. Anazao's lawyer told the Tampa Bay Times last month that the FDA had used "inflammatory language" to make the case to Congress for more regulatory powers.
The Compounding Shop says on its website that it opened in 1997 as St. Petersburg's first compounding-only pharmacy. The pharmacy has a second location in Riverview.
Jodie Tillman can be reached at [email protected] or (813) 226-3374.