Teva Pharmaceuticals has expanded its voluntary recall of losartan potassium tablets after detecting a possible human carcinogen in the blood pressure medication.
The Israel-based drugmaker recalled six more lots of bulk losartan potassium USP Tablets (two lots of 50 mg strength and four lots of 100 mg strength) due to the detection of a nitrosamine impurity, according to the FDA.
The source of the NMBA impurity was detected in one lot of active pharmaceutical ingredient (API), manufactured by Hetero Labs Limited, which was used in the manufacturing of the six (6) bulk lots of these drug products.
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, according to the FDA.
Losartan potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients. The bulk lots were sold exclusively to Golden State Medical Supply, Inc. of Camarillo, California. Golden State Medical Supply, Inc. packaged these bulk products under its own label and distributed retail bottles of 30, 90 and 1000 tablets to their customers.
The affected losartan potassium tablets being recalled are described as:
- 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.
Consumers affected by the recall should continue taking their medication and ask their doctor or pharmacist about alternatives or replacement drugs. Discontinuing a medication without a replacement could cause a patient more harm than continuing the drug.
Customers and patients with medical-related questions, who wish to report an adverse event, or quality issues about the Teva products being recalled under the Golden State Medical Supply label should contact Teva Medical Information by phone at: 888-838-2872, option 3, then, option 4. Live calls are received Monday-Friday, 9 a.m.-5 p.m. Eastern Time with voicemail available 24 hours/day, 7 days/week or by email at firstname.lastname@example.org.