9/4/13 - CLARIFICATION: Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse...

CLARIFICATION: Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events By a News Reporter-Staff News Editor at Biotech Week Specialty Compounding, LLC is voluntarily recalling all lots of sterile medications within expiry. Note: 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. The recall was initiated after reports of bacterial infection affecting 15 patients at two Texas hospitals, Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area, whose treatment included IV infusions of calcium gluconate from Specialty Compounding. There is a potential association between the infections and the medication at this time. No calcium gluconate was shipped outside of the state of Texas. If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening (see also Specialty Compounding, LLC). "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." 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. Specialty Compounding is notifying its customers by telephone, fax, electronic mail and/or regular mail of this recall. Users or recipients of these products should immediately discontinue use and return the recalled unexpired products to Specialty Compounding. quoted from here