Specialty Compounding recalls sterile medications

The Food and Drug Administration on Sunday announced a recall of all products produced and distributed for sterile use by Specialty Compounding because of concerns about bacterial infections

The Cedar Park, Texas, company is recalling all lots of its unexpired sterile compounded medications sold since May 9, including all strengths and dosage forms. The company announced the recall late Friday.

The agency said the recall follows reports of bacterial infections affecting 15 patients at two Texas hospitals,

Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area. All of the cases involved treatment that included IV infusions of calcium gluconate from Specialty Compounding.

There is a potential association between the infections and the medication, according to the notice. It adds that if there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.

The company said the recalled products were sent directly to patients nationwide, with the exception of North Carolina. They were also distributed directly to hospitals and physician offices in Texas.

Specialty Compounding, a subsidiary of Peoples Pharmacy Inc., is notifying its customers by telephone, fax, electronic mail and/or regular mail of this recall.