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U.S. Department of Health and Human Services

Safety

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Sodium Polystyrene Sulfonate Suspension

Audience: Pharmacists, hospital risk managers, other healthcare professionals

[Posted 07/16/2008] Roxane Laboratories, Inc. informed healthcare professionals of the recall of two lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; lot 856396A Exp April 2010, and lot 856693A Exp May 2010), a product used to treat hyperkalemia. A sample of one of the affected lots tested positive for a strain of yeast, which could potentially affect immunocompromised patients. Symptoms of a yeast infection range from thrush, skin rash, and blood infections. If patients develop an infection they should consult their physician. Pharmacists should determine if any of the referenced product has been dispensed and retrieve it. Additionally, pharmacists and wholesalers of the product should discontinue distribution and use of the referenced lots immediately and contact the manufacturer regarding returning the product.

[July 14, 2008 - Recall - Roxane Laboratories, Inc.]