Irbesartan Joins List Of Recalled Medications, Along With Losartan And Valsartan
A massive recall of some of the world’s leading brands of hypertension medication continues as the manufacturer or Irbesartan and Irbesartan HCTZ tablets has also announced consumers should return the medications.
Prinston Pharmaceutical Inc., which does business as Solco Healthcare LLC, is recalling one lot of Irbesartan and seven lots of Irbesartan HCTZ tablets after trace amount of an unexpected impurity were found, according to the Food and Drug Administration (FDA).
This is the third popular blood pressure medication to be recalled since September. Losartan and valsartan tablets made in China and India have already been recalled.
Tablets of Irbesartan and Irbesartan HCTZ which were manufactured by Zhejiang Huahai Pharmaceuticals in China and contain N-nitrosodiethylamine (NDEA).
NDEA, which occurs naturally in certain foods, drinking water, air pollution and industrial processes, has been classified as a probable human carcinogen by the International Agency for Research on Cancer.
Prinston has not received any reports of adverse events related to the recall.
Irbesartan and Irbesartan HCTZ are used to control high blood pressure and for the treatment of heart failure. Irbesartan in combination with amlodipine plus hydrochlorothiazide is used to control high blood pressure.
Patients should contact their pharmacist or physician about alternative treatment prior to returning their medication.
Patients who are on Irbesartan should continue taking their medication until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.
The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product.
Adverse reactions or quality problems associated with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, by regular mail or by fax or online at www.fda.gov/medwatch/report.htm.
Earlier this month, Torrent Pharmaceuticals Limited expanded a recall of Losartan potassium tablets due to the detection of NDEA.
The massive recalls started when the European Medicines Agency removed valsartan products from the market in 22 countries in Europe, plus Canada.
Authorities found that ingredients made by Hetero Labs of India and Zhejiang Huahai Pharmaceutical Company and Zhejiang Tianyu Pharmaceuticals, both of China, contained a known carcinogen.
In September, the FDA announced that retesting of valsartan supplies marketed in the U.S. under the Torrent brand also found NDEA.
Since then, more than 50 companies around the world have recalled the contaminated valsartan products, according to Reuters.
Authorities believe the contamination has been present since 2012, when governments both here and abroad loosened manufacturing standards.
The certificates for the manufacturers of the contaminated products have since been suspended, but the recall of the products continues.
Locally, losartan and valsartan are two of the biggest selling hypertension medications, say pharmacists, who also say they’ve been inundated with calls since the recalls began.
Retail pharmacies who are in possession of any unused Irbesartan Tablets, 300 mg/90 ct. and Irbesartan-HCTZ Tablets, 300mg/12.5mg, 150mg/12.5mg, in 30 and 90 count should immediately return the product, the FDA said.
Prinston is arranging for return of all recalled products. Instructions for returning recalled products are given in the recall letter.
For more information, visit the FDA website, www.fda.gov/Safety/Recalls, or contact your pharmacist or health care provider.