Mylan Recalls 15 Lots of Valsartan Products in US

Megan Brooks

November 21, 2018

Mylan Pharmaceuticals has recalled 15 lots of medicines containing valsartan because of the presence of the probable carcinogen N-nitrosodiethylamine (NDEA), marking the latest recall of tainted sartan products in the United States.

The Mylan recall, announced November 20, includes six lots of amlodipine/valsartan tablets (including the 5 mg/160 mg, 10 mg/160 mg, and 10 mg/320 mg strengths), seven lots of valsartan tablets (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of valsartan and hydrochlorothiazide tablets (320 mg/25 mg strength).

The recalled lots were distributed in the United States between March 2017 and November 2018. Full details of the specific lots recalled are available on the US Food and Drug Administration (FDA) website.

On November 19, the European Medicines Agency (EMA) announced a ban on sales of valsartan made by Mylan Laboratories of Hyderabad, , after some batches were found to contain NDEA.

Mylan is notifying its American distributors and customers of the recall by letter and is arranging for return of all recalled products. Wholesalers, retailers, and consumers with recalled product should contact Stericycle between 8 AM and 5 PM EST at 1-888-406-9305 to return the product.

The Sartan Saga Continues

The FDA and EMA are continuing to investigate the presence of NDEA and another probable carcinogen, N-nitrosodimethylamine (NDMA), in angiotensin II receptor blockers.

Contaminated sartan products first surfaced back in July, when NDMA was detected in some valsartan products manufactured by China's Zhejiang Huahai Pharmaceuticals (ZHP).

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

But the problem is not limited to ZHP, and has now spread to several other companies, with subsequent recalls of tainted sartan products.

Last week, as reported by Medscape Medical News, the FDA and Sandoz Inc announced a nationwide recall of one lot of losartan potassium hydrochlorothiazide tablets because of trace amounts of NDEA detected in the API losartan, which was manufactured by ZHP.

Earlier this month, the FDA alerted providers about certain lots of irbesartan from SciGen Pharmaceuticals, owing to the presence of NDMA. The agency also announced that Aurobindo Pharma Ltd, which manufactures the API for ScieGen's irbesartan products, recalled all unexpired lots of its irbesartan API supplied to the AMerican market with NDEA.

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


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