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Title: Nationwide Voluntary Recall of 2 Lots of Sodium Polystyrene Sulfonate Suspension in the United States and Puerto Rico
URL: http://www.pslgroup.com/dg/225DDA.htm
Doctor's Guide
July 16, 2008

COLUMBUS, Ohio -- July 16, 2008 -- The US Food and Drug Administration has stated that Roxane Laboratories, Inc., is conducting a nationwide voluntary recall of 2 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).

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.

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 2 lot numbers listed. No other Roxane Laboratories, Inc. products or lots are impacted by this recall.

Pharmacists who may have dispensed Sodium Polystyrene Sulfonate Suspension, USP, 15-g/60-mL Unit dose bottles from lots 856396A and 856693A are instructed to contact those patients to return the affected product to the pharmacist.

SOURCE: US Food and Drug Administration

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