Boehringer Ingelheim Subsidiary Recalls Drug Due to Yeast Contamination
Roxane Laboratories, Boehringer Ingelheim’s generic subsidiary, recalled two lots of sodium polystyrene sulfonate because one lot tested positive for a strain of yeast that could pose a risk of infection, including sepsis, to immunocompromised patients.
The drug is used to treat hyperkalemia, high levels of potassium in the blood that can be associated with kidney disease. The two recalled lots consist of approximately 100,000 units, the company said.
The product initially passed final testing and met specifications. But the company detected a strain of yeast during final product testing of subsequent production lots, Roxane said.
The firm identified the source of the yeast as a shipment of high-density polyethylene bottles received from a supplier. It then tested two previously released lots, one of which tested positive for the yeast strain. Another lot, which used the same polyethylene bottles, did not test positive for the strain but was recalled as a precaution.
“The company is committed to evaluating and implementing corrective and preventive actions to mitigate future recurrence,” Roxane said.