Roxane Laboratories Recalls Sodium Polystyrene Sulfonate Suspension Over Contamination IssuesJul 16, 2008 | Parker Waichman LLP
Roxane Laboratories, Inc. is recalling two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles distributed in the U.S. and Puerto Rico. Sodium Polystyrene Sulfonate Suspension is used to treat hyperkalemia (an elevated blood level of the electrolyte potassium). The tainted drugs could be contaminated with yeast.
Lots involved in the recall include NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010. Roxane Laboratories said in its recall notice that sample from product lot 856396A tested positive for a strain of yeast, which could potentially affect immunocompromised patients. Roxane Laboratories believes that 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. So far, no infections have been linked to these tainted products.
Pharmacists who may have dispensed Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles from the affected lots are instructed to contact those patients to return the affected product to the pharmacist.
Pharmacists and wholesalers that have any Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles from either lots should discontinue distribution and use of these lots immediately and contact Capital Returns at 888.839.7837 for any questions regarding the recall returns. Requests for additional information should be referred to Roxane Laboratories Technical Product Information at 800.962.8364.
Patients who have been informed by a pharmacist of this recall should return the affected product to the pharmacy. Those who have not been contacted should check their product to determine if it is from either of the two affected lots: Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles from Lot 856396A Exp April 2010, or Lot 856693A Exp May 2010. If the product has either of these two lot numbers on the bottle, patients should pharmacist for further instructions.
The Sodium Polystyrene Sulfonate Suspension recall is limited only to the two lots. No other Roxane Laboratories, Inc. products or lots are impacted by this recall.