Sodium Polystyrene Sulfonate Suspension Recall

On July 14, 2008, Roxane Laboratories Inc. and the FDA announced a nationwide Sodium Polystyrene Sulfonate Suspension recall for two lots of the medication after it was discovered that it may be contaminated with yeast.

The recall applies to Sodium Polystyrene Sulfonate Suspension, USP, 15g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Expiry April 2010 and Lot 856693A Expiry May 2010). This is a generic medication prescribed to treat hyperkalemia, a condition characterized by elevated levels of the electrolyte potassium in the blood. A sample of the drug manufactured by Roxane Laboratories tested positive for a yeast strain, which could have an adverse effect on patients with a weak immune system.

Immunocompromised patients are at a greater risk of developing a yeast infection. Symptoms of problems that could be caused by the contaminated Sodium Polystyrene Sulfonate Suspension include:

• Thrush
• Sepsis (blood infections)
• Skin Rash

Although two lots of Sodium Polystyrene Sulfonate Suspension were recalled, only one of these lots tested positive for yeast contamination. However, the same batch bottles were used for the packaging for lots of the medication.

Pharmacists have been notified of the recall, and the manufacturer has requested the pharmacists notify consumers who filled a prescription for Sodium Polystyrene Sulfonate Suspension from the recalled lots. Alternatively, consumers can check the details on the bottle and contact their pharmacist for further details.

According to a statement released by Roxane Laboratories, no other lots or products are affected by the recall. Additional information can be obtained directly from the manufacturer at (800) 962-8364.