Roxane Laboratories, Inc.
Roxane Laboratories, Inc. voluntarily recalled, nationwide, two manufacturing 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). A sample from product lot 856396A tested positive for a strain of yeast, which could potentially affect immunocompromised patients. This may be attributed to yeast contamination in one lot of high-density polyethylene bottles received from a supplier. There are various manifestations of yeast infections. The risk of developing a yeast infection depends on how immunocompromised the patient is. Additionally, there are a range of symptoms in a yeast infection from thrush, skin rash, and blood infections (sepsis). If patients develop an infection they should consult their physician. Due to the potential risks that could occur in immunocompromised patients, Roxane Laboratories recalled lot 856396A. Although there have been no testing failures associated with lot 856693A, this additional lot is was included in the recall as a precautionary measure because the same lot of bottles was used in both finished product lots.
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