More Tainted Valsartan Products Recalled

Megan Brooks

Disclosures

January 04, 2019

Aurobindo Pharma USA has recalled 80 lots of medicines containing valsartan because of the presence of the probable carcinogen N-nitrosodiethylamine (NDEA), marking the latest recall of tainted valsartan products in the United States.

The recall to the consumer level, announced December 31, includes amlodipine valsartan tablets, valsartan hydrochlorothiazide tablets, and valsartan tablets. The product was distributed nationwide. Full details of the specific lots recalled are available on the US Food and Drug Administration (FDA) website.

To date, Aurobindo Pharma USA has not received any reports of adverse events related to this recall.

The company is notifying its distributors and customers by telephone and in writing to discontinue distribution of the specific lots being recalled and to notify holders of their subaccounts. Aurobindo Pharma USA, Inc, is arranging for return of all recalled products to Inmar/CLS Medturn. Instructions for returning recalled products are provided in the recall letter.

For questions about this recall, Aurobindo Pharma can be contacted by telephone at 1.866.850.2876 (option 2) or email at pvg@aurobindousa.com.

In a separate January 3 release, the FDA announced that Torrent Pharmaceuticals is expanding its voluntary recall to include eight additional lots of losartan potassium tablets, owing to trace amounts of NDEA found in an active ingredient manufactured by Hetero Labs.

The company initially recalled two lots of losartan 100-mg tablets on December 20, 2018.

The expanded recall to the consumer level involves losartan 25-mg, 50-mg, and 100-mg tablets that were distributed nationwide. A full list of the recalled products is available on the FDA’s website.

Torrent Pharmaceuticals has not received any reports of adverse events related to the recalled products, according to the agency.

For questions about this recall, Torrent Pharmaceuticals can be contacted by telephone at 1-800-912-9561 or email at Medinfo.Torrent@apcerls.com.

No End in Sight to the 'Sartan Saga

Valsartan is an angiotensin II receptor antagonist used to treat hypertension and heart failure. Aurobindo is the latest company to recall tainted valsartan products.

Contaminated products first surfaced in July, when N-nitrosodimethylamine (NDMA) was detected in some valsartan products manufactured by Zhejiang Huahai Pharmaceuticals (ZHP) in China.

In late September, the FDA announced a ban on imports of active pharmaceutical ingredients and of finished drug products produced by ZHP after an inspection of the company's Chuannan facility in Linhai uncovered numerous manufacturing and quality-control problems. ZHP is the subject of an FDA import alert. In mid-October, the European Medicines Agency (EMA) announced measures for increased oversight of substances produced by ZHP.

The problem is not limited to ZHP. It has now spread to several other companies, with subsequent recalls of tainted valsartan products.

In November, Mylan Pharmaceuticals recalled 15 lots of medicines containing valsartan, and Sandoz Inc recalled one lot of losartan potassium hydrochlorothiazide because of the presence of NDEA.

Also in November, the FDA alerted providers about certain lots of irbesartan from SciGen Pharmaceuticals, owing to the presence of NDMA.

The FDA and the EMA are continuing to investigate the presence of NDEA and NDMA in angiotensin II receptor blockers.

Adverse reactions or quality problems associated with the use of valsartan products should be reported to FDA's MedWatch Adverse Event Reporting Program.

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