FDA Reports: Compounding Pharmacy Voluntarily Recalls Medicine
The U.S. Food and Drug Administration (FDA) just reported that a Texas compounding pharmacy has voluntarily recalled all of its sterile items after 15 patients became infected. This is just one of the many recalls by compounding pharmacies. Ever since the first major outbreak of fungal meningitis from a compounding pharmacy based in Boston occurred late last year, a series of recalls had followed. Now, the latest recall has politicians pressing for some major changes in order to keep the public safe.
"Because of the potential association between the hospital-based infections and sterile compounded medications produced by Specialty Compounding, we are voluntarily recalling all sterile products out of an abundance of caution," Ray Solano, RPh, pharmacist in charge at Specialty Compounding, said in a statement posted on the FDA's website. "We deeply regret the impact this recall has on our patients and the hospitals that we serve, but patient safety must always be our first concern."
According to the FDA, there were 15 victims treated at two hospitals in Texas. The patients had developed bacterial bloodstream infections caused by the organism, Rhodococcus equi after they received calcium gluconate injections. Specialty Compounding located in Cedar Park, TX manufactured the injections. The calcium gluconate injections are used to treat cardiac arrest, calcium deficiency, or elevated levels of potassium. Ever since the meningitis outbreak last September that caused 63 fatalities and infected 749 people throughout the nation, the FDA has increased inspections of these companies.
"I am saddened to learn of yet another incident where patients have been potentially harmed due to tainted drugs produced by a compounder," said Senator Tom Harkin, a Democrat from Iowa according to USA Today. "The Senate has before it a unique opportunity to take bipartisan action and improve the safety of compounded drugs. I hope that the Senate takes up and passes the bipartisan Pharmaceutical Quality, Security, and Accountability Act as soon as possible so that the FDA and state boards of pharmacy can have the guidance necessary to carry out their work to protect all Americans."
The legislation that Senator Harkin is talking about would improve the safety of drugs produced by compounding pharmacies. The new legislation would specify how much authority the state and federal authorities have over these companies.