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Home https://server7.kproxy.com/servlet/redirect.srv/sruj/smyrwpoii/p2/ Health https://server7.kproxy.com/servlet/redirect.srv/sruj/smyrwpoii/p2/ Teva Pharmaceuticals Expands Patient-Level Losartan Recall

Teva Pharmaceuticals Expands Patient-Level Losartan Recall



Teva Pharmaceuticals USA is expanding its nationwide recall to include six additional lots of bulk losartan potassium USP tablets: two lots of 50mg tablets and four lots of 100mg 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 the active pharmaceutical ingredient API) produced by Hetero Labs Limited and used in the manufacture of the tablets, according to a June 10 release release.

At the end of April, the company recalled 35 lots of bulk losartan potassium 25 mg and 1

00 mg USP tablets after NMBA was detected in six lots of APIs, again manufactured by Hetero Labs.

In both recalls, the bulk lots were sold exclusively to the Golden State Medical Supply of Camarillo, California, which packed the bulk product under its own label and It distributes it in retail bottles of 30, 90, and 1000 tablets.

Teva notified the 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 distributing and return the recalled product for instructions issued by Golden State.

Teva recommends that patients continue taking their losartan medication and contact their pharmacist, physician or medical provider for advice on an alternative treatment

Details of the specific lot numbers and the expiration date of the newly recalled products are available here

For more information about the recall or report an adverse event, contact Teva Medical by phone at 1-888 -838-2872, option 3, then option 4 (live calls received from 9am to 5pm Eastern Time, Monday to Friday; voicemail available 24 hours / day, 7 days / week); or by email at druginfo@tevapharm.com

Follow Patrice Wendling on Twitter: @pwendl . For more from theheart.org | and and ; n = f.fbq = function () {n.callMethod?
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