FDA finds problems with 30 of 31 compounding pharmacies inspected by agency

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by Jay Pate

More than 700 people have become ill and more than 50 of them have died as a result of a meningitis outbreak that was traced to unsanitary conditions at the New England Compounding Center, a “compounding pharmacy” in Massachusetts that manufactured thousands of vials of contaminated steroids. Since then, the FDA conducted 31 unannounced inspections in 18 states of other compounding pharmacies. The agency found conditions that could create a risk of contamination in 30 of the 31 facilities inspected. Among the problems found that could cause contamination of drugs were unidentified black particles floating in vials of supposedly sterile medicines, rust and mold in clean rooms where drugs are made, improper air flow, and clothing that left workers’ skin exposed.

Since the NECC incident there have been seven additional recalls of sterile compounded and repackaged drug products by different pharmacies. For example:

  • On April 17, 2013, Balanced Solutions Compounding Pharmacy, LLC announced a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired. The recall is being initiated due to concerns associated with quality control processes, which present a lack of sterility assurance. During a recent inspection the FDA sampled chromium chloride injection from Balanced Solutions Compounding Pharmacy and identified gram negative bacteria in the product, which Balanced Solutions Compounding Pharmacy, LLC had previously recalled.
  • On April 15, 2013, ApothéCure, Inc. announced it was voluntarily recalling all lots of sterile products compounded by the pharmacy that are not expired to the user level. The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes. In the event a sterile product is compromised patients are at risk for serious and possible life threatening infections.
  • On April 15, 2013 NuVision Pharmacy announced a voluntary recall of all unexpired lots of lyophilized compounds HcG 5000IU-5ml and Sermorelin/GHRH6-5ml to the user level. The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during the FDA inspection.
  • On April 05, 2013, Green Valley Drugs announced it was is voluntarily recalling all lots of all sterile products compounded, repackaged, and distributed by the pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. The recall of sterile products is conducted based on observations of clean room personnel and certain aseptic techniques.
  • On March 26, 2013, Pallimed Pharmacy announced it was is voluntarily recalling all sterile compound products dispensed since January 1, 2013 to the user level. The recall resulted from a recent inspection conducted by the U.S. Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy where visible particulates (filaments) were observed in vials of sterile compounded products: TRIMIX, BIMIX (Lot 02252013@3), ALPROSTADIL, DMSO 50 PERCENT – IRRIGATION (Lot 03122013@19), and BACTERIOSTATIC WATER FOR INJECTION (Lot 01072013@28). The potential public health risks are unknown as the particulate matter has not yet been identified. However, particulate matter has the potential to damage or obstruct blood vessels, which could induce emboli, cause systemic allergic reaction, or cause tissue responses to the foreign material. At this time a total of 5 affected vials were discovered.
  • On March 20, 2013, Med Prep Consulting, Inc. announced a voluntary recall of all lots of all products compounded at its facility. The level of recall is to the user, that is, regional hospital pharmacies and related departments, and physician’s office practices. The recall resulted from the pharmacy being notified by a Connecticut hospital, that it observed visible particulate contaminants in 50 ml bags of MAGNESIUM SULFATE 2GM IN DEXTROSE 5% IN WATER, 50ML FOR INJECTION intravenous solution confirmed to be mold. These were unique and distinct lots compounded and dispensed by the pharmacy to the Connecticut hospital. At this time a total of five (5) contaminated bags were discovered. In an abundance of caution, the pharmacy included all compounded products in the voluntary recall due to lack of sterility assurance. Administration of an intravenous product found to be contaminated with mold, could result in a fatal infection in a broad array of patients.
  • On March 20, 2013, Clinical Specialties announced it was voluntarily recalling All Lots of All Sterile products repackaged and distributed by the pharmacy due to lack of sterility assurance. The recall of all sterile products is conducted in follow-up to concerns regarding practices at the site which cannot assure the sterility of the products. The expanded recall follows the firm’s initial recall of Avastin due to reports of five patients who have been diagnosed with serious eye infections associated with the use of the product. Although there has been no evidence of contamination with sterile products other than the specified Avastin lots, Clinical Specialties has decided in the interest of their patients to proceed with this recall process. The Center for Disease Control and Prevention (CDC) notified the FDA of these endophthalmitis infections, which occur inside the eyeball. Endophthalmitis after intravitreal injection is a serious complication that can lead to permanent loss of vision. Clinical Specialties Compounding repackaged the Avastin into individual single-use syringes from the manufactured vials labeled as sterile. A compromised sterile product puts patients at risk for serious and possible life threatening infection.

For a complete list of the products that being recalled and for other details regarding these recalls, visit the FDA’s website.

The lawyers at Heygood, Orr & Pearson have made it a career priority to hold drug manufacturers and pharmacies accountable and responsible for their actions. If you or a loved one has experienced the tragedy of losing a family member as a result of a delinquent pharmacy, drug manufacturer, compounding company or health care provider, you and your family deserve answers to your questions. If your loss was as a result of a defective drug or perhaps a physician’s negligence, you have the right to demand that the negligent drug company, pharmacist or physician be held responsible.

Contact the law firm of Heygood, Orr & Pearson for a free consultation so we can help you determine the best way to protect your legal rights and interests. You can reach us by calling our toll-free hotline at 1-877-446-9001, or by filling out our free case evaluation form located on this page.