Yet Another Compounding Pharmacy Issues Recall

Green Valley Drugs, of Henderson, Nevada, is voluntarily recalling all lots of its sterile products. Drug recall lawyers at Pintas & Mullins Law Firm announce that this is the fifth recall since the outbreak of fungal meningitis from the New England Compounding Center (NECC) killed 51 people and sickened 700 more.

Since the fatal NECC outbreak in late 2012, the FDA has investigated more than 30 similar compounding pharmacies and kept a watchful eye on dozens more. Those recent inspections led to national recalls, warning letters, and shut-down notices for Med Prep Consulting, Pallimed Solutions, Clinical Specialties, Medi-Fare Drug and Home Health Center, and now, Green Valley Drugs.

There are more than 7,000 compounding pharmacies in the U.S., which are licensed and overseen not by the FDA, but by individual state’s boards of health. Such facilities mix and manufacture prescriptions on a patient-by-patient basis, to fill unique and specific prescriptions that large drug companies, such as Pfizer or Johnson & Johnson, cannot. There is such a large demand for these drugs, however, that hundreds of facilities started (illegally) mass-manufacturing these products, without notifying or adhering to the FDA and its sterility standards.

The results of this practice have proven dangerous, even devastating to some patients. The recall initiated by Clinical Specialties, for example, was spurred by the death of one man and sickening of dozens of others from eye injections that were contaminated with bacteria. The drug, Avastin, is a cancer drug, although the company was mixing it in apparently unsterile doses to treat patients with a rare eye condition. Another recall, by Med Prep Consulting, was initiated after visible particles of mold were found in at least five of its IV medications. The pharmacy agreed to suspend shipping and manufacturing operations while the syringes, bags, and vials of premixed solutions were recalled.

This most recent recall by Green Valley Drugs was based on observations made by investigators into the facility’s clean room personnel and certain aseptic techniques. The recall affects all lots of its sterile products, and notification letters went out yesterday, on April 11, 2013. The products were distributed nationwide, and a full list of the affected products can be found here.

Fortunately, this recall is in effort of sterility assurance, and no ill or injured patients have yet been reported. Green Valley stated that, until further notice, health care providers should stop using all lots of its sterile products and immediately return them to the company’s headquarters in Nevada.

The increase in oversight that led to these numerous recalls and shut-down notices is long past overdue. Many experts noted that the deadly fungal meningitis outbreak was merely a calamity waiting to happen. This is because compounding pharmacies lack regulation due to the specificities of its products. There is no conceivable way that the FDA could be responsible for the magnitude of new, specialized medicines that are requested by health care facilities on a daily basis. So, this responsibility of oversight was given to state boards of health.

Unfortunately, too many state boards entrusted the pharmaceutical companies to largely govern themselves, which led, as it always does, to abuse of the system. Dr. Margaret Hamburg, FDA commissioner, recently asked Congress for explicit power to regulate those compounding pharmacies that are producing drugs on larger scales. She stated that an alarmingly high number of these facilities are not cooperating with the federal agency, refusing to let it inspect facilities and creating complex legal barriers to prevent them from doing so.

These measures are most likely being enacted to buy time, to improve facility conditions before they can be inspected. Since the fungal meningitis outbreak, the NECC has filed for bankruptcy and is facing hundreds of lawsuits along with criminal prosecution, and undoubtedly, these other compounding pharmacies do not want to suffer the same fate.

Drug recall lawyers at Pintas & Mullins Law Firm urge anyone injured by a contaminated drug from NECC, Med Prep, Pallimed, Clinical Specialties, Medi-Fare Drug and Home Health Center, of Green Valley Drugs, to contact a skilled attorney as soon as possible.


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