Teva Expands Voluntary Recall of Losartan Potassium

Originally initiated on April 25, 2019, Teva Pharmaceuticals has just announced that it is expanding its voluntary consumer-level recall of losartan potassium tablets. The expanded recall, initiated on June 10, 2019, spans across the United States. 

Due to the detection of the impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), Teva is now recalling 6 additional lots of bulk losartan USP Tablets (two lots of 50 mg strength and four lots of 100 mg strength).

“Based on the available information, there is a potential risk of developing cancer in a few patients following long-term use of products containing high levels of NMBA,” the pharmaceutical company said in a statement.

The newly added bulk lots added to Teva’s recall list were sold exclusively to Golden State Medical Supply, Inc. of Camarillo, California. According to Teva, the medical supply company packaged these products under its own label. They were distributed in retail bottles of 30, 90, and 1000 tablets to customers.

The affected losartan potassium tablets being recalled 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.
• 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.

“The tablets, which have been packaged and sold by Golden State Medical Supply, Inc., will be sub-recalled from their customers and patients,” Teva explained. “Distributors and retailers that have product being recalled should immediately stop distribution, quarantine all remaining product in their control, and return the recalled product per the instructions given to them by Golden State Medical Supply, Inc.”

Losartan potassium is indicated to treat hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients.

—Julie Gould

Reference:

US Food and Drug Administration. Teva Pharmaceuticals USA, Inc. Expands Voluntary Nationwide Recall of Losartan Potassium to 50 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply, Inc. [press release]. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-pharmaceuticals-usa-inc-expands-voluntary-nationwide-recall-losartan-potassium-50-mg-and-100-mg. Published June 10, 2019. Accessed June 12, 2019.