The U.S Food and Drug Administration issued a press release on Sunday announcing a major recall of all products designed for sterile use manufactured by the Texas pharmaceutical company Specialty Compounding LLC. This is after recent complaints received by the federal agency of blood infections caused by the company’s calcium gluconate infusions.
The target of the recall is those issued since May 9, 2013. Health care providers as well as the patients were warned to stop using the products, quarantine it, and return it to the pharmaceutical company immediately.
Almost all states had stocks of the product except for North Carolina. Some hospitals, such as Texas, had directly received the recalled products through the physicians.
About 15 patients from different Texas hospitals who had received injections containing about 2 grams of calcium gluconate had developed bacterial bloodstream infections. These are patients who have low calcium levels in the body. The FDA had identified the bacteria Rhodococcus equi found in the infusions.
“The FDA believes that use of these products would create an unacceptable risk for patients," said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, in the press release. "Giving a patient a contaminated injectable drug could result in a life-threatening infection.”
Bacterial bloodstream infection is life-threatening as it may lead to extreme damage to the body organs due to blood clotting due to the inflammation. The worst case that may happen to the patient when this infection occur is a sudden drop in the blood pressure resulting to lungs, kidney, and liver failure. The complications will then lead to death.
The FDA had already involved the Centers for Disease Control and Prevention (CDC) and the Texas health officials in investigating the extent of the infection.
Those who would like to seek help may contact the FDA online or call directly at 1-800-FDA-0178.
