Teva Pharmaceuticals USA is expanding its nationwide recall to include six additional lots of bulk losartan potassium USP tablets: two lots of 50-mg tablets and four lots of 100-mg tablets.
The recall, to the patient level, is due to the detection of the probable carcinogen N-Methylnitrosobutyric acid (NMBA), above the US Food and Drug Administration’s interim acceptable exposure limit of 9.82 ppm.
The source of the impurity was traced to one lot of active pharmaceutical ingredient (API) produced by Hetero Labs Limited and used in the manufacturing of the tablets, according to a June 10 news release.
In late April, the company recalled 35 lots of bulk losartan potassium 25-mg and 100-mg USP tablets after NMBA was detected in six lots of API, again manufactured by Hetero Labs.
In both recalls, the bulk lots were sold exclusively to Golden State Medical Supply, of Camarillo, California, which packages the bulk product under its own label and distributes it in retail bottles of 30, 90, and 1000 tablets.
Teva notified Golden State about the presence of the impurity and the recall of the additional six lots. Distributors and retailers with the affected product are advised to immediately stop distribution and return the recalled product per instructions issued by Golden State.
Teva recommends that patients continue taking their losartan medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.
Details on the specific lot numbers and expiration dates of the newly recalled products are available here.
For more information about the recall or to report an adverse event, contact Teva Medical by phone at 1-888-838-2872, option 3, then option 4 (live calls received from 9 AM to 5 PM Eastern Time, Monday to Friday; voicemail available 24 hours/day, 7 days/week); or by email at email@example.com.