Lupin Pharmaceutical Inc. is voluntarily recalling certain batches of lrbesartan Tablets and lrbesartan and Hydrochlorothiazide Tablets to the consumer level. As part of Lupin's ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosolrbesartan. Although Lupin has received no reports of illness that appear to relate to this issue, the company, out of an abundance of caution, is recalling all batches of lrbesartan Tablets USP 75mg, 150mg and 300mg and lrbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the US.
Lupin discontinued the marketing of lrbesartan and lrbesartan and HCTZ tabs in Jan 2021.
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