More Sterile Compounded Products Recalled

May 16, 2013

4216206720_5e080c0365.jpgDrug recall lawyers at Pintas & Mullins report of yet another compounding pharmacy recall, this one initiated by The Compounding Shop of St. Petersburg, Florida. The recall was triggered by problems uncovered during FDA health inspections.

The Compounding Shop is currently in the midst of alerting its customers of the recall while the FDA is recommending healthcare professions quarantine the drugs and not administer any to patients. Since the contaminations at the New England Compounding Center (NECC) in late 2012, there have been about eight recalls spurred by the immense increase in FDA oversight into these compounding facilities.

The outbreak of fungal meningitis from NECC contaminated products was the result of unsterile practices at the company. Several lots of the sterile injections were tainted with fungal bacteria and then injected into patients throughout the country, resulting in the death of 55 people and sickening of more than 740 others.

This devastating contamination forced healthcare officials to re-consider how compounding pharmacies are managed and regulated. Previously, for many years, oversight of these facilities was left largely up to individual state's health departments. Compounding pharmacies were originally intended to mix unique pharmaceuticals for patients with specific needs. The drugs would be ordered by physicians or pharmacists for those patients, and the compounding pharmacies would mix them.

Due to the recent increase in our dependence on pharmaceuticals, these compounding pharmacies have become exceedingly popular, and have even started compounding drugs in mass quantities. Unsurprisingly, the facilities started to overwhelm state health departments, leaving many of the pharmacies to largely regulate themselves, which in turn resulted in the accumulation of unsafe, unsterile conditions.

In light of these developments, the FDA recently started a comprehensive check on these compounding facilities. So far in 2013, along with the nine recalls recalls, the FDA has issued an impressive 43 inspectional observation warnings to U.S. compounding facilities. These observations (compiled in a "483 Form") require the company to promptly respond to the FDA addressing each item, indicating agreements and either providing a timeline for corrections or clarification requests.

Despite the federal agency's attempted increase in oversight, several compounding facilities refuse to cooperate, and with more than 7,000 pharmacies in the U.S., the FDA is having trouble controlling them. The FDA commissioner, Dr. Margaret Hamburg, recently asked Congress for more explicit power in regulating these pharmacies, particularly those that are manufacturing drugs on a large scale. She stated that many of these larger facilities are refusing to let the FDA examine their operations, creating complex legal barriers.

Undoubtedly, these pharmacies are trying to avoid the implications the NECC is now subject to because of its unsterile practices. In the wake of the fungal meningitis outbreak, the NECC filed for bankruptcy and is facing hundreds of lawsuits along with criminal prosecution.

So far, the following compounding pharmacies have issued recalls: Pallimed Solutions (MA), NuVision Pharmacy (TX), Nora Apothecary and Alternative Therapies (IN), MedPrep Consulting (NJ), Green Valley Drugs (NV), Clinical Specialties Compounding Pharmacy (GA), Balanced Solutions Compounding Pharmacy (FL), ApotheCure (TX), and now, The Compounding Shop (FL).

Drug recall lawyers at Pintas & Mullins encourage all American patients to stay up-to-date on FDA alerts, warnings, and recalls. If you or a loved one was seriously injured by a contaminated or dangerous drug, you may be entitled to significant compensation. Our attorneys have decades of experience working with victims of dangerous pharmaceuticals, and always offer free, confidential legal consultation.