What to Know
- The FDA expanded its list of recalled products and updated its list of those unaffected
- Traces of N-nitrosodimethylamine, a "probable human carcinogen," was found in the active ingredient valsartan in the recalled products
- Not all products containing valsartan are contaminated and being recalled
Another drugmaker is recalling a medication used to treat high blood pressure and heart failure over concerns that tablets could be contaminated with a cancer-causing agent.
Drug maker Aurobindo Pharma USA is voluntarily recalling 80 lots Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP.
The U.S. Food and Drug Administration reported that traces of N-nitrosodimethylamine (NDMA), a "probable human carcinogen," was found in the active ingredient valsartan in the recalled products.
The recalled medications were distributed nationwide. The New Jersey-based company has not received any reports of adverse effects related to the drugs as of Dec. 31, 2018, when the recall was announced, the FDA said.
A full list of the recalled products is available here. Products can be identified by checking the product name, manufacturer details, and batch or lot number on the bottles. Expiration dates range from May 2019 to March 2021.
Valsartan tablets are used to control high blood pressure and for treatment of heart failure. The FDA says patients who are prescribed Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP 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.”
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If a patient's medicine is included in the recall, they should contact their health care professional to discuss alternative treatment options before returning their medication.
Consumers can contact the company at 1-866-850-2876 or by email at: pvg@aurobindousa.com.
Aurobino’s recall follows a growing list of companies recalling their blood pressure medication in the last year. In November, Teva Pharmaceuticals voluntarily recalled two of its drugs over the same concerns. In July, the FDA announced a recall of several medicines containing valsartan due to traces of NDMA contamination. A month later, the agency expanded the recall list of medications that contained the active ingredient valsartan over concerns that it could be contaminated with the cancer-causing agent.
"The agency continues to investigate and test all angiotensin II receptor blockers (ARBs) for the presence of NDEA and N-Nitrosodimethylamine (NDMA) and is taking swift action when it identifies these impurities that are above interim acceptable daily intake levels," the FDA said in a news release.
The FDA also updated the list of valsartan products under the recall and the list of valsartan products not under recall.
The agency encourages patients and health care professionals to report any adverse reaction to the FDA’s MedWatch program.
