Teva Pharmaceuticals USA expands its nationwide recall by adding six additional batches of Losartan Potassium USP tablets: two batches of 50 mg tablets and four batches of 100 mg tablets.
is due to the detection of the probable carcinogen N-methylnitrosobutyric acid (NMBA), which exceeds the US Food and Drug Administration's allowable limit of 9.82 ppm.
The source of the contaminant was recycled to a lot of the active ingredient (API) manufactured by Hetero Labs Limited and used in the manufacture of the tablets, according to a press release dated June 10th.
In late April, the company called 35 batches of losartan potassium 25 mg and 100 mg USP tablets after NMBA was detected in six batches of API, which in turn were manufactured by Hetero Labs. In both recalls, the bulk batches were sold exclusively to Golden State Medical Supply of Camarillo, Calif., Which sells the bulk product under its own label and sells it in retail bottles of 30, 90 and 1
Teva informed Golden State about the presence of pollution and the recall of the additional six lots. Dealers and retailers of the affected product are advised to discontinue distribution immediately and return the recalled product in accordance with Golden State's instructions.
Teva recommends that patients continue to take their losartan medications and contact their pharmacist, doctor or healthcare provider for advice. An alternative treatment.
For details on the specific lot numbers and expiration dates of the newly recalled products, click here.
For more information on recalling or reporting an adverse event, contact Teva Medical at 1-888-838-2872, Option 3, then Option 4 (live calls from 9:00 am to 5:00 pm Eastern Time, Monday through Friday; Voicemail 24 hours a day, 7 days a week available); or by e-mail to firstname.lastname@example.org.