Drug recall lawyers at Pintas & Mullins Law Firm report of two additional compounding pharmacies that recently issued major recalls. The first was Florida-based Balanced Solutions Compounding Pharmacy and involves all lots of its sterile drug products. The second was an Indianapolis compounding pharmacy, Nora Apothecary Alternative Therapies.
Nora Apothecary is recalling nearly 100 of its compounded drugs after federal investigators discovered problems in the facility’s safety policies. The recalled drugs were made on or before April 19, 2013. During inspections, the FDA found quality control problems that could have potentially affected the sterility of its products. Lack of sterility can cause infections, ranging from mild to fatal.
One of the more extreme examples occurred late in 2012, when an outbreak of fungal meningitis affected hundreds of patients throughout the country. The outbreak, caused by the unsterile environment of the New England Compounding Center, ultimately killed 51 people and sickened 700 more. Since this, the FDA and state authorities have investigated 55 similar compounding pharmacies, and are keeping a watchful eye on dozens more.
The FDA Commissioner, Margaret A. Hamburg, recently assured the House Energy and Commerce subcommittee that the agency is being much more aggressive now than it ever has before with these types of facilities. Compounding pharmacies, unlike major drug manufacturers, mix pharmaceuticals for individual patients based on their unique prescriptions.
Because there is no way the FDA could be responsible for the oversight of these new, specialized medicines, of which there are millions on a daily basis, it was delegated to each state’s board of health. However, due to industry lobbying groups and state’s failure to adequately oversee the facilities, the FDA was left with ambiguous authority over compounding pharmacies, which turned out to have catastrophic consequences.
Unfortunately, the practice on compounding medication has evolved in recent decades and outgrown the law in many areas. Many pharmacies are now mass-producing drugs, more resembling larger manufacturers (such as Pfizer) that are regulated by the FDA. The federal agency is now seeking the right to inspect these pharmacies and obtain samples of drugs and records.
So far there have been nine recalls of compounded and repackaged drugs, one of the most recent being from Balanced Solutions. The FDA encouraged health care centers who have received products from this facility to immediately quarantine the products and follow recall instructions. Additionally, patients who were administered any of the recalled drugs from any of these nine pharmacies should contact their physicians.
In an investigation, the FDA sampled chromium chloride injections from
the pharmacy and identified bacteria, which can cause disease and infection
in patients. Balanced Solutions is a faction of Axium Healthcare Pharmacy, Inc.
A Representative from California said that there are currently no clear lines determining whether it should be the FDA or the states governing compounding pharmacies. For almost two decades, the International Academy of Compounding Pharmacists has held great influence over regulators, lobbying aggressively and successfully to keep FDA authority out of the nation’s pharmacies. The group also informed its members to avoid FDA inspections.
Dangerous drug lawyers at Pintas & Mullins Law Firm will continue to report on all recalls stemming from compounding pharmacies, and the regulatory process surrounding them. If you or a loved one was seriously injured by a drug manufactured at any of these facilities, you may be entitled to significant compensation for past and future medical bills, lost wages, and pain and suffering.