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Nationwide FDA Recall: ‘All sterile products’ from Specialty Compounding

Posted in Recalls

On August 11th of this year, the United States Food and Drug Administration issued a “nationwide recall of all products produced and distributed for sterile use by Specialty Compounding, LLC, Cedar Park, TX.  There have been recent reports of bacterial bloodstream infections potentially related to the company’s calcium gluconate infusions.”[1]

So far, “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.  Then the patients developed bacterial bloodstream infections caused by Rhodococcus equi.”[2]  It is the position of the FDA that these infections are related to the gluconate injections.

According to USA Today, this is “the latest in a series of recalls since last year’s outbreak of fungal meningitis.”[3]

The FDA warns that “All sterile use products produced and distributed by Specialty Compounding are being recalled and none of these products should be used by patients or administered to patients. 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.”[4] (emphasis added)

Use of these products thought by Dr. Janet Woodcock, director of the Center for Drug Evaluation and research at the FDA, to “create an unacceptable risk for patients,”[5] and Dr. Woodcock states that “Giving a patient a contaminated injectable drug could result in a life-threatening infection.”[6]

In a statement regarding the recall from Ray Solano, R.Ph., a leading pharmacist at Specialty Compounding, the company “deeply [regrets] the impact this recall has on our patients and the hospitals that we serve, but patient safety must always be our first concern.”[7]

CNN reports that “Over the past year, the FDA has stepped up its investigations of compounding facilities after dozens of people died and hundreds more were made sick by contaminated injections from a compounding facility in Massachusetts” and “A bill with bipartisan support is under consideration in Congress: The Pharmaceutical Compounding Quality and Accountability Act would step up some of that regulation.”[8]

With “[compounding drugs making up] about 1% to 3% of the U.S. prescription drug market,”[9] the sterility of these products is of upmost importance.