Teva Pharmaceuticals recalls Losartan Potassium tablets

Teva Pharmaceuticals USA is recalling 35 lots of bulk Losartan Potassium USP tablets used for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients.

The product contains trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA), a potential human carcinogen.

The lots were sold exclusively to Golden State Medical Supply of Camarillo, Calif. Golden State Medical Supply packages this bulk product under its own label and distributes in retail bottles of 30, 90, and 1000 tablets.

Teva has not received any reports to date of adverse events related to the lots being recalled.

The finished product lots included in this voluntary recall and listed below were sold by Teva in bulk containers.

The bulk tablet lots were repackaged into 44 finished products lots for further distribution by Golden State Medical Supply under its product label.

The recalled tablets are described as:

• Losartan Potassium tablets, USP 25 mg, are light-green, film-coated, teardrop-shaped biconvex tablet with “LK 25” on one side and ">" on the other side.
• Losartan Potassium tablets, USP 100 mg, are dark green, film-coated, oval-shaped biconvex tablets with “LK100” on one side and ">" on the other side.

What to do

Patients taking Losartan Potassium tablets are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an 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.

Patients with medical-related questions, who wish to report an adverse event, or quality issues about the recalled products may contact Teva Medical Information by at (888)838-2872, option 3, then, option 4, Monday-Friday, 9:00AM – 5:00PM (ET) with voicemail available 24 hours/day, 7 days/week, or by email at druginfo@tevapharm.com.

Patients wishing to return product may contact Teva’s product recall processor (Inmar) to obtain instructions and a return kit for returning their medication.

Contact Inmar at (877) 789-2065 from 9 am to 5 pm (ET) Monday – Friday) or by email Inmar at: tevarecalls@inmar.com.

Inmar will provide the materials needed to return their medication and instructions for reimbursement.