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Prinston Pharmaceutical recalls irbesartan for impurity in active pharmaceutical ingredient

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Prinston Pharmaceutical, which does business as Solco Healthcare, announced that it has voluntarily recalled several lots of irbesartan and irbesartan HCTZ tablets to treat patients with high BP and HF.

These lots contain a traceable amount of N-nitrosodiethylamine (NDEA), an impurity found in an active pharmaceutical ingredient by Zhejiang Huahai Pharmaceutical that is classified as a probable human carcinogen, according to an announcement from the company. As Cardiology Today previously reported, the impurity is the same as was found in a previous recalls of irbesartan, in addition to the various recalls for valsartan.

The recall affects one lot of irbesartan and seven lots of irbesartan HCTZ tablets, although the company has not received reports of adverse events, according to the announcement. The following are the affected lots:

• irbesartan tablets, 300 mg, 90 count, NDC code 43547-376-09, lot number 331B18009, expires February 2021, distributed Aug. 9, 2018;

• irbesartan/HCTZ, 300 mg/12.5 mg, 30 count, NDC code 43547-331-03, lot number 327A18001, expires March 2021, distributed July 10, 2018;

• irbesartan/HCTZ, 300 mg/12.5 mg, 30 count, NDC code 43547-331-03, lot number 327A18002, expires March 2021, distributed July 10, 2018;

• irbesartan/HCTZ, 300 mg/12.5 mg, 90 count, NDC code 43547-331-09, lot number 327B18008, expires March 2021, distributed July 10, 2018;

• irbesartan/HCTZ, 300 mg/12.5 mg, 90 count, NDC code 43547-331-09, lot number 327B18009, expires March 2021, distributed July 10, 2018;

• irbesartan/HCTZ, 150 mg/12.5 mg, 30 count, NDC code 43547-330-03, lot number 325D18004, expires March 2021, distributed July 10, 2018;

• irbesartan/HCTZ, 150 mg/12.5 mg, 90 count, NDC code 43547-330-09, lot number 325B18004, expires March 2021, distributed Aug. 24, 2018; and

• irbesartan/HCTZ, 150 mg/12.5 mg, 30 count, NDC code 43547-330-03, lot number 325D18005, expires March 2021, distributed July 10, 2018.

The company recommends that patients should contact their physician or pharmacist regarding an alternative treatment before they return their medication. Patients should not stop their treatment until they discuss alternative treatments, as discontinuation can increase the risk for harm.

The company is also notifying customers and distributors in writing and over the phone to discontinue distribution of the recalled lots and to notify their subaccounts, according to the announcement. The letter also includes instructions on how to return the affected lots.

Retail pharmacies who are in possession of the recalled lots are also instructed to return the lots.