Texas Drug Recall: Pharmacy Taking Back Meds after Causing Bacterial Infection in 15 Patients

Specialty Compounding, LLC, a subsidiary of People's Pharmacy Inc. in Cedar Park Texas, is voluntarily recalling all lots of unexpired sterile products due to reports of adverse effects, the Food and Drug Administration posted on its official website Friday. The recall is applicable to all unexpired sterile compounded products dispensed since May 9, 2013 in all strengths and 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, R. Ph., 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 was prompted by 15 cases of bacterial infection in patients who allegedly took the drug. The patients reportedly received an infusion of calcium gluconate 2 grams in sodium chloride 0.9 percent for injection, supplied by Specialty Compounding, said NBC News. The patients received the said medication at two Texas hospitals, Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area. According to CBS News, the drug is used to treat calcium deficiencies and is also used in patients with too much potassium in the blood.

The reports said the 15 patients developed bacterial bloodstream infections due to the presence of the Rhodococcus bacteria after receiving the intravenous drug. The bacterial infection brought about certain symptoms among the patients including fever and pain.

The FDA noted that if the the calcium gluconate drugs produced by Specialty Compounding had microbial contaminations, serious and life threatening infections will abound. The drugs are intended to be sterile, the agency added.

Specialty Compounding's Cedar Park facility has once been found questionable in terms of "testing practices and a lack of some procedures in place to establish drug sterility" earlier in March, says CBS News. Citing a "483" document from the FDA, violations like improper clothing for people processing the drugs and inadequate testing for harmful microorganisms in the drugs were recorded.

The recalled calcium gluconate products were distributed directly to hospitals and physician offices in Texas and were also made available to patients directly in all other states except for North Carolina. To return product or request assistance related to this recall, users should contact Specialty Compounding at 512-219-0724, Monday through Friday, between 10:00 a.m. and 5:00 p.m. CDT.