Cedar Park, Texas-based Specialty Compounding has issued a voluntary recall of all lots of sterile medications that have not expired.
Specialty Compounding, a subsidiary of Peoples Pharmacy, issued the recall after receiving reports of bacterial infection of 15 patients at Corpus Christi (Texas) Medical Center-Doctors Regional and Corpus Christi (Texas) Medical Center-Bay Area. The patients' treatment included IV infusions of calcium gluconate from Specialty Compounding. "There is a potential association between the infections and the medication at this time," the news release stated.
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All unexpired sterile compounded products dispensed since May 9 are being recalled. These products were distributed to hospitals and physician offices in Texas and directly to patients in every state except North Carolina.
This recall comes shortly after the release of a Government Accountability Office report on sterile compounding oversight. "Drug Compounding: Clear Authority and More Reliable Data Needed to Strengthen FDA Oversight" states that the Food and Drug Administration's limited authority over and data on drug compounding puts public health at risk. GAO recommended Congress clarify the FDA's role in drug compounding oversight and recommended the FDA ensure its databases on inspections related to compounded drugs are reliable and timely and that they differentiate drug compounders from manufacturers.
Update Aug. 16: The FDA issued a clarification to the initial news release, stating, "An earlier version of this news release indicated that the recall applied to all unexpired sterile compounded products dispensed since May 9, 2013; however, the recall applies to any sterile medication that has not reached its expiration date, including all strengths and dosage forms."
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