Following a recent site inspection at The Compounding Shop in St. Petersburg, Fla., the Food and Drug Administration is telling health care providers, hospital supply managers, and pharmacists not to use drugs produced at and distributed from this site. The FDA says that preliminary findings from the inspection raise concerns about a potential lack of sterility assurance for sterile drugs. Inspectors say they observed production practices at the facility that could affect the sterility of the products. The agency has also recommended that the company remove all of their sterile products from the market.
Drug products sold as sterile products, but have a microbial contamination can put a patient at risk for serious infections. Infections can lead to life-threatening illnesses or death, especially in patients who are already ill and have a weak immune system. The FDA encourages patients who may have received any product produced by The Compounding Shop to talk with their health care provider.
The FDA’s findings at The Compounding Shop comes after last year’s meningitis outbreak that claimed the lives of nearly three dozen people and sickened more than 400 others. That epidemic occurred as a result of unsterile conditions at a compounding pharmacy, The New England Compounding Center, in Massachusetts.
According to reports, NECC manufactured and shipped more than 17,000 vials of tainted methylprednisolone acetate injections to 24 states. The tainted steroids were used to treat patients suffering from chronic back pain as well as pain in their joints such as knees, shoulders and hips. Inspections of the facility revealed several quality control issues, including a failure to properly sanitize equipment and utensils to prevent contamination and failing to appropriately maintain the building where their products were being manufactured.
The Philadelphia medical malpractice attorneys at Messa & Associates are experienced at handling cases involving serious injuries or deaths as a result of infections resulting from unsterile products. Our extremely skilled team of medical malpractice attorneys and medical experts is dedicated to ensuring you receive proper compensation for your personal injuries. If you or a loved one has suffered a serious infection or death after coming in contact with a contaminated medical product, contact the medical malpractice attorneys of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or submit a free online inquiry.
Joseph L. Messa, Jr. is the founding partner of Messa & Associates, P.C. He is an AV-rated attorney (highest rating available), listed in the Bar Register of Preeminent Lawyers. Read More