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Lupin Pharmaceuticals Recalls its Blood Pressure Medication Due to N-nitrosoirbesartan Contamination

According to an online news report posted on stjohnsource.com, Lupin Pharmaceuticals is recalling two lots of its blood pressure medications.  The V.I. Department of Health published the recall in a media release.  The V.I. Department of Health stated that on October 14, 2021, the Lupin Pharmaceuticals recalled its Irbesartan Tablets and its Irbesartan and Hydrochlorothiazide […]

Lupin pharmaceuticals recalls its blood pressure medication due to n-nitrosoirbesartan contamination

N-nitrosoirbesartan Contamination

According to an online news report posted on stjohnsource.com, Lupin Pharmaceuticals is recalling two lots of its blood pressure medications.  The V.I. Department of Health published the recall in a media release.  The V.I. Department of Health stated that on October 14, 2021, the Lupin Pharmaceuticals recalled its Irbesartan Tablets and its Irbesartan and Hydrochlorothiazide Tablets due to the presence of N-nitrosoirbesartan.  N-nitrosoirbesartan is known human carcinogen.

Lupin Pharmaceuticals reported that this recall is part of the company’s ongoing assessment and analysis of its products.  The company’s testing of API batches were found to be above the limit for the impurity, N-nitrosoirbesartan.  Although Lupin Pharmaceuticals has not received any reports of injuries, illnesses, or deaths related to the recall.  However, Lupin Pharmaceuticals decided to initiate the recall out of precaution.

According to Lupin’s recall notice, the company is recalling all lots of Irbesartan Tablets USP 75mg, 150mg, and 300mg, and all batches of its Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg that were sold in the United States.

As part of the recall notice, Lupin is urging patients prescribed the medications to not stop taking the medication and to speak with their pharmacists or medical provider regarding an alternative treatment.

Lupin Pharmaceuticals is the third-largest pharmaceutical manufacturer in the United States.

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