Teva expands nationwide recall of losartan

Teva Pharmaceuticals has recalled an additional six lots of bulk losartan potassium tablets, expanding a nationwide recall originally initiated in April, the FDA announced June 11.

The recall affects two lots of 50 milligram strength and four lots of 100 milligram strength.

The recall is a result of the detection of N-Nitroso-N-methyl-4-aminobutyric acid, a potentially carcinogenic impurity.

The impurity was detected in one lot of an active pharmaceutical ingredient made by Hetero Labs. This active ingredient was then used by Teva to manufacturer six bulk lots of the tablets.

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

Read the full recall announcement here.

 

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