A Texas pharmacy has recalled all of its compounded sterile products after 15 patients in two hospitals became ill from what federal health officials said were tainted sterile infusions.
“The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all products produced and distributed for sterile use by Specialty Compounding, LLC, Cedar Park, Tex.,” the FDA said in a statement.
“The FDA has received reports of 15 patients from two Texas hospitals who received an infusion of calcium gluconate 2 grams in sodium chloride 0.9 percent for injection, supplied by Specialty Compounding,” it added. These patients developed bacterial infections in their bloodstreams following the infusions.
The substance is used to treat conditions related to low calcium levels. No patients have died.
Director of the FDA’s Center for Drug Evaluation and Research, Dr. Janet Woodcock, said in a statement, “Giving a patient a contaminated injectable drug could result in a life-threatening infection.”
“Facilities, health care providers and patients who have received the products since May 9, 2013 should immediately discontinue use, quarantine the products, and return the products to Specialty Compounding,” the FDA advises. “According to information provided by the firm, the recalled products were distributed directly to patients nationwide, with the exception of North Carolina. Recalled products were also distributed to hospitals and physicians’ offices in Texas.”
Since last year’s deadly outbreak of fungal infections was linked to a Massachusetts compounding pharmacy, the FDA has increased their inspection efforts. That outbreak resulted in the death of 63 patients and affected almost 800 people in 20 states. Many patients developed meningitis, stroke, abscesses and/or other complications due to the tainted injections.
A thorough inspection of the New England Compounding Center confirmed that products made there were contaminated with bacteria and fungi. The compounding pharmacy responsible for this mishap had shipped several different products in large quantities nationwide and has since been shut down.
As a result of the stringent inspections by the FDA, several other recalls have been issued. The FDA is asking Congress for more power to regulate the compounding pharmacies in an effort to prevent further outbreaks. Presently, each state is supposed to regulate compounders while the FDA regulates the drug manufacturers. But the FDA argues that many pharmacies, like the New England Compounding Center and the recent Texas Specialty Compounding, who manufacture products in large batches, operate more like manufacturers than pharmacies.
Lawmakers are developing legislation that would toughen rules for compounding pharmacies who custom-mix medicines. A Senate bill would give the FDA authority over compounding pharmacies that produce sterile drugs without a prescription and ship them across state lines.
Do you feel that the FDA should have a closer watch over these compounding pharmacies? Especially following the tragic incident that took place at the New England compounding pharmacy, you would think these companies would be careful to avoid contamination. Tell us what you think about the latest recall in Texas. For more information, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).