Compounding pharmacy lawyers at Pintas & Mullins Law Firm confirm that Specialty Compounding, based in Cedar Park, Texas, recently announced a recall of all its sterile products. About 15 patients have already been hospitalized with blood infections after receiving injections produced at Specialty Compounding.
The FDA announced on Sunday, August 11, 2013 that Specialty Compounding was recalling its entire line of sterile products used to inject pharmaceuticals over concerns of bacterial bloodstream infections. No products by Specialty manufactured before May 9, 2013 should be used, and should be quarantined and returned to the company immediately.
The recalled products were distributed directly to patients in 49 states (not affecting North Carolina), as well as to hospitals in Texas. To date, 15 patients at two hospitals in Texas had to be admitted to ICUs due to bacterial bloodstream infections after receiving injections of calcium gluconate. These injections are meant to aid patients with low calcium levels, such as those with high potassium and heart disease.
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The bloodstream bacteria causing infections is an organism known as Rhodococcus equi (R. equi), which is commonly found in dry and dusty soil. R. equi is associated with significant mortality, as it can be difficult to eradicate and treatment can be challenging. Treatments may include prolonged combination antibiotic therapy, sometimes in addition to surgical therapy.
The FDA has actively increased inspections into compounding pharmacies since the September 2012 of fungal meningitis from the New England Compounding Center, which killed 63 people and sickened nearly 750 others. Since that outbreak, dozens of recalls have been announced, and legislation has been introduced into Congress for increased FDA oversight into these facilities.
Compounding pharmacies were initially established to create, manufacture, and distribute specific, personalized medications to certain patients. As the pharmaceutical industry grew, so did the amount of specialized medications, and compounding pharmacies began producing these drugs en-masse, shipping thousands of products at a time.
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Unfortunately, the FDA has struggled to keep up with these pharmacies, which are present in every state, and are supposed to be overseen by that state’s departments of health and pharmacy boards. State departments, however, simply do not have the resources or man-power to constantly regulate and enforce all facilities, so the burden has recently been placed on the FDA, which currently has ambiguous legal authority over compounding pharmacies.
As a result, a bill was recently placed before the U.S. Senate, entitled the Pharmaceutical Quality, Security, and Accountability Act. The bill would enable the FDA and state boards of pharmacy to have the guidance and authority necessary to enact inspections, citations, and enforce measures to keep American patients safe.
The legislation would improve the safety of compounded drugs by clearly defining the amount of oversight authority state and federal officials have over these companies. It would also protect U.S. drug supply chains by establishing a uniform prescription drug -tracking framework.
We last reported on a compounding pharmacy recall in mid-May 2013, when The Compounding Shop, based in Florida,announced a recall. At that time, we affirmed that the FDA had already issued 43 inspectional observation warnings to compounding pharmacies, which has grown to 60 since then.
The recent spotlight on compounding pharmacies has illuminated not only the widespread, uneven quality of their products, but the unregulated, self-governing nature of these companies as well. A 2003 Government Accountability Office report stated that as many as 10% of all U.S. prescriptions come from compounding pharmacies, which has surely grown in the past decade.
Drug recall lawyers at Pintas & Mullins Law Firm affirm that the FDA is currently working with the CDC to determine how widespread the Specialty Compounding contamination is. If you or a loved one was seriously sickened by a drug produced at a compounding pharmacy, you have important legal rights, and may be entitled to significant compensation for your medical bills and lost wages through a lawsuit against the manufacturer.