Teva Expands Recall of Bulk Losartan Tablets

In another recall of “sartan”-containing products, Teva Pharmaceuticals USA has expanded its voluntary recall to the consumer level in the US of losartan potassium tablets, used in antihypertensive drugs. The expanded recall includes six 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 an impurity that is above the US Food and Drug Administration’s (FDA) interim acceptable exposure limit. Teva had first initiated a voluntary recall of 35 lots of bulk losartan potassium tablets in late April 2019.

The detected impurity was of N-nitroso-N-methyl-4-aminobutyric acid (NMBA) and was found to be above the FDA’s acceptable exposure limit of 9.82 ppm. The source of the NMBA impurity was detected in one lot of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited, used in the manufacturing of the six bulk lots of these drug products.

The bulk lots were sold exclusively to Golden State Medical Supply of Camarillo, California. Golden State packaged these bulk products under its own label and distributed retail bottles of 30, 90, and 1,000 tablets.

Teva notified Golden State of the impurity in Hetero’s API, and Teva is recalling the six lots of bulk losartan potassium tablets sold to that company. Teva reports that the tablets, which have been packaged and sold by Golden State Medical Supply, will be sub-recalled from their customers and patients. Teva advises that distributors and retailers that have this product should immediately stop distribution, quarantine all remaining product in their control, and return the recalled product per the instructions given to them by Golden State.

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 Type 2 diabetes, left ventricular hypertrophy and nephropathy.

Source: Teva Pharmaceuticals USA and FDA

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