August 12, 2013 – The U.S. Food & Drug Administration (FDA) announced today that Texas-based compounding pharmacy Specialty Compounding, LLC, has issued a nationwide recall for all lots of medications it has processed since May 9. To date, at least 15 people have been diagnosed with a rare bacterial infection after being administered injections of calcium gluconate at a pair of Texas hospitals. In response to this and a number of other recent compounding pharmacy recalls, the FDA is asking Congress for increased oversight and authority over these operations.
Free Specialty Compounding Calcium Injection Recall Lawsuit Evaluation: If you or a loved one has been injured by contaminated medicine from Specialty Compounding, LLC, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against Specialty Compounding, LLC, and we can help.
What’s the Problem?
According to the FDA press release, patients at the Corpus Christi Medical Center Bay Area and Doctors Regional facilities developed severe infections caused by Rhodococcus equi bacteria after receiving injections to treat conditions caused by low calcium.
“… the patients developed bacterial bloodstream infections caused by Rhodococcus equi. These infections are thought to be related to the infusions,” the FDA said. “Cultures from an intact sample of calcium gluconate compounded by Specialty Compounding show growth of bacteria that are consistent with Rhodococcus species.”
What is Rhodococcus Equi?
Rhodococcus equi is a soil-borne bacteria that typically causes zoonotic infections in grazing animals (most often horses and foals). Although it rarely affects humans, in recent years R equi has been increasingly identified as a pathogen in patients with compromised immune systems.
R equi was initially documented in foals in 1923, and first found in humans in 1967. Since then, R equi has become an increasingly prevalent opportunistic pathogen in immunocompromised patients, especially those suffering from HIV and AIDS. Unfortunately, R equi infection is associated with a high rate of mortality, due to the fact that the organism can be difficult to locate and eradicate. Increased public awareness of R equi infection may promote early diagnosis, which will improve the prognosis of many patients. Treatment typically involves a combination of antibiotic drugs, sometimes together with surgical intervention.
FDA Requests Greater Authority Over Compounding Pharmacies
In response to numerous recent problems with compounding pharmacies in the United States, the FDA has petitioned Congress for greater authority over regulating these operations. The worst incident involving a compounding pharmacy in recent years occurred at the Framingham, Mass. based New England Compounding Center (NECC) in October 2012, where tainted corticosteroid injections were linked to an outbreak of fungal meningitis. Nearly 750 people were injured in 20 states, including 63 individuals who died as a direct result of their illness.
Do I Have a Specialty Compounding, LLC Calcium Injection Recall Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Specialty Compounding, LLC Calcium Injection Recall Lawsuits. We are handling individual litigation nationwide and currently accepting new Rhodococcus equi bacterial infection cases in all 50 states.
Free Specialty Compounding, LLC Calcium Injection Recall Lawsuit Evaluation: If you or a loved one has been injured by contaminated medicine from Specialty Compounding, LLC, you should contact our law firm immediately. You may be entitled to compensation by filing a Specialty Compounding, LLC Calcium Injection Recall suit and we can help.