Texas Hospital IV Infections Lead to Another Compound Pharmacy Recall

An outbreak of bacterial infections among individuals who received certain IV infusions at two Texas hospitals could be linked to a local compounding pharmacy, which has now recalled all of its supposedly sterile drugs.  

On August 9 the FDA announced a Specialty Compounding, LLC drug recall after at least 15 patients fell ill at Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area. The patients received IV infusions of calcium gluconate that were mixed at the compounding pharmacy.

The recall affects all unexpired sterile drugs distributed by the pharmacy since May 9, including all strengths and all dosage forms.

“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,” said Ray Solano, the pharmacist in charge at Specialty Compounding. “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.”

The recall comes as federal officials and lawmakers weigh how to regulate compounding pharmacies in the wake of a fungal meningitis outbreak linked to one such pharmacy, which has killed 63 people and sickened more than 700 nationwide. That outbreak was tracked back to the New England Compounding Center (NECC), which also subsequently recalled all products and was then shut down by health officials. The company has since declared bankruptcy as a growing number of fungal meningitis lawsuits have been filed by individuals who received the tainted injections.

In the aftermath, the FDA was criticized for having known there were problems at NECC but not taking action sooner. Since then the agency has cracked down on compounding pharmacies nationwide, resulting in a number of recalls.

Lawmakers are considering several pieces of legislation aimed at clarifying the FDA’s authority over compounding pharmacies, which has been made uncertain following a number of legal rulings in recent years.

Specialty Compounding distributed its recalled drugs to doctors and hospitals in Texas. The company recommends that users and recipients of its drugs should immediately discontinue use and return the drugs to Specialty Compounding. Those with questions can call (512) 219-0724.