YOUNGSTOWN, Ohio (WKBN) ̵
The expanded recall includes six lots of bulk losartan potassium tablets (two lots of 50 mg strength and four lots of 100 mg strength).
The company said the pills may contain higher than normal levels of N-nitroso-N-methyl-4-aminobutyric acid (NMBA).
The original recall was initiated on April 25.
The company said the NMBA impurity resulted from an ingredient manufactured by Hetero Labs Limited and was used in six bulk lots of the medication.
There is a potential risk of developing cancer in a few patients following long-term use of the products containing levels of NMBA, the company said.
Losartan potassium is used to treat high blood pressure and nephropathy in Type 2 diabetic patients.
The medication was sold exclusively to Golden State Medical Supply, Inc. of Camarillo, California, which packaged the pills under its own label and distributed them nationwide.
The affected losartan potassium tablets impacted on this latest recall include: Losartan potassium tablets, USP 50 mg, are green, film-coated, oval-shaped biconvex tablets with "LK 50" on one side and ">" on the other side
Patients taking losartan potassium tablets are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding alternative treatment. The immediate risk of harm to a patient's health is likely to be higher if the medicine is stopped abruptly without any alternative treatment
For more information, visit FDA.gov for complete recall details.