Irbesartan & Irbesartan/Hctz Recall – IMMEDIATE ACTION NEEDED

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Date: October 21, 2021
To: Health Plan of San Joaquin (HPSJ) Pharmacies and Providers & Practices
From: HPSJ Pharmacy Department
Subject: Irbesartan & Irbesartan/Hctz Recall – IMMEDIATE ACTION NEEDED
Business: Medi-Cal Managed Care

We are sending this alert because you may have one or more patients who filled a prescription for Irbesartan Tablets or Irbesartan/Hydrochlorothiazide Tablets within the last six months (180 days).

Lupin Pharmaceuticals Inc. is voluntarily recalling the below mentioned batches of Irbesartan Tablets and Irbesartan/Hydrochlorothiazide Tablets to the consumer level because testing revealed that certain API batches (though not finished product batches) were above the specification limit for the impurity N-nitrosoirbesartan.

Risk Statement: N-nitrosoirbesartan impurity is a probable human carcinogen (asubstance that could cause cancer) based on results from laboratory tests.

This table shows the products subject to this recall.

If you have questions, please contact our HPSJ Customer Service team at 1.888.936.PLAN (7526).

Posted on October 21st, 2021 and last modified on September 8th, 2022.