Specialty Compounding Sterile Products — Recall

April 2, 2013

Specialty Compounding, LLC has announced a voluntary nationwide recall of all lots of unexpired sterile products. The recall applies to all unexpired sterile compounded products dispensed since May 9, 2013, including all strengths and dosage forms.

The recall was initiated after reports of bacterial infections affecting 15 patients at two Texas hospitals, Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area. The patients were treated with IV infusions of calcium gluconate from Specialty Compounding. There is a potential association between the infections and the medication.

Recalled products were distributed directly to hospitals and physician offices in Texas. Recalled products were also sent directly to patients located nationwide with the exception of North Carolina.

August 12 — FDA safety alert

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