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Roxane Laboratories Recalls Sodium Polystyrene Sulfonate Suspension

Filed July 15th, 2008 amy

Roxane Laboratories, Inc., is conducting a nationwide 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). Sodium Polystyrene Sulfonate Suspension is used to treat hyperkalemia (an elevated blood level of the electrolyte potassium). This recall is being initiated because a sample from product lot 856396A tested positive for a strain of yeast, which could potentially affect immunocompromised patients. The risk of developing a yeast infection depends on how immunocompromised the patient is.

Due to the potential risks that could occur in immunocompromised patients, Roxane Laboratories is voluntarily recalling lot 856396A. Although there have been no testing failures associated with lot 856693A, this additional lot is also being included in the recall as a precautionary measure because the same lot of bottles was used in both finished product lots. All other product parameters were within specification and product efficacy is not impacted. There have been no complaints or adverse
events reported for the affected lots. This recall is limited to the two lot numbers listed. No other Roxane Laboratories, Inc. products or lots are impacted by this recall.

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