Aurobindo Recalls 80 Lots of Valsartan Tablets

Aurobindo Pharma USA is voluntarily recalling 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level, due to the detection of trace amounts N-nitrosodiethylamine (NDEA). An unexpected impurity, NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen by the International Agency for Research on Cancer (IARC).

Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP were distributed nationwide. The company is arranging for return of all recalled products.

The action taken by Aurobindo is the latest recall related to valsartan. Since July, recalls involving multiple companies and products have been announced, due to the presence of NDMA in active pharmaceutical ingredient (API) supplied by manufacturer Zhejiang Huahai Pharmaceutical Co Ltd, in Linhai, Taizhou Zhejiang, China. Subsequent international investigations expanded to include all manufacturers of API and finished drugs in the ARB class and have resulted in additional recalls of valsartan, irbesartan, and losartan-containing products found to contain NDMA and N-Nitrosodiethylamine (NDEA), known animal and suspected human carcinogens.

RELATED

• Valsartan Recall: FDA Issues Warning to API Manufacturer
• Mylan Expands Voluntary Nationwide Recall of Valsartan Tablets
• Alembic: Valsartan Products Not Subject to Recall

Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP are indicated to control high blood pressure and for the treatment of heart failure. According to the FDA, patients who prescribed these products should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

In its December 31, 2018 recall announcement, Aurobindo stated it had not received any reports of adverse events related to this recall, at that time. A full list of Aurobino’s recalled lot numbers can be accessed on the FDA website.

Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product. Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at pvg@aurobindousa.com.

Reference

FDA. Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity [news release]. Silver Spring, MD; December 31, 2018; FDA website. http://www.pharmacytimes.com/link/241?rel=0" ?rel=0" . Accessed January 2, 2019.