Teva Pharmaceuticals USA expands its nationwide recycling to include six more lots of bulk losartan potassium tablet USP: two 50 mg tablets and four 100 mg tablets.
The recurrence, at the patient's level, is due to the detection of possible N-Methylnitrosobutyric acid (NMBA) pneumonia, above the temporary acceptable US exposure limit of 9.82 ppm.
The source of contamination was followed by a lot of active pharmaceutical drugs (APIs) produced by Hetero Labs Limited and used in making tablets, according to a news release on June 10.
In late April, the company recalled 35 bulk bulk losartan potassium 25-mg and 100-mg USP tablets after NMBA was detected in six APIs, reproduced by Hetero Labs.
At the same time, bulk lots are sold exclusively at Golden State Medical Supply, Camarillo, California, featuring bulk products under its own label and distributes it to bottles of 30, 90, and 1
Teva told the Golden State about the dehydration and the restoration of six additional lots. Distributors and retailers with the affected product are advised to immediately stop the distribution and return the recorded product to any instructions issued by Golden State.
Teva recommends that patients continue to take their losartan medicines and contact their pharmacist, doctor, or medical provider for advice on an alternative treatment.
Details on specific lot numbers and expiration dates of new recalled products are available here.
For more information about recalling or reporting a bad event, contact Teva Medical by phone at 1-888 -838-2872, option 3, then option 4 (receive live call from 9:00 to 5:00 Eastern Time, Monday to Friday; available voicemail 24 hours / day, 7 days / week); or by email at firstname.lastname@example.org.