Another Tainted 'Sartan' Recalled for Impurity

Megan Brooks

November 16, 2018

The saga of contaminated sartans reaching the US market continues, with the US Food and Drug Administration (FDA) and Sandoz Inc announcing a nationwide recall to the consumer level of one lot of losartan potassium hydrochlorothiazide tablets.

As with some other recent sartan recalls, this latest recall is due to trace amounts of the probable human carcinogen N-nitrosodiethylamine (NDEA), detected in the active pharmaceutical ingredient (losartan), which was manufactured by Zhejiang Huahai Pharmaceuticals (ZHP), the company at the center of the tainted valsartan crisis. ZHP is the subject of an FDA import alert.

The recalled Sandoz product (losartan potassium hydrochlorothiazide, USP 100 mg/25 mg) was manufactured by Lek Pharmaceuticals of Ljubljana, Slovenia. It is packaged in 1000-count plastic bottles with NDC 0781-5207-10, lot number JB8912, and an expiration date of 06/2020.

To date, Sandoz has not received any reports of adverse events related to this recall, the company said in a news release posted on the FDA website.

Investigation Ongoing

The FDA is continuing to investigate the presence of NDEA and another probable carcinogen, N-nitrosodimethylamine (NDMA), in angiotensin II receptor blockers (ARBs) and has pledged to take "swift action" when it identifies unacceptable impurities in active pharmaceutical ingredients (API) and finished drug products.

Contaminated sartan products first surfaced back in July, when NDMA was detected in some valsartan products manufactured by ZHP. The problem then spread to several other companies, with subsequent recalls of tainted products.

In late September, the FDA announced a ban on imports of API and finished drug products produced by China's ZHP after an inspection of the company's Chuannan facility in Linhai, which uncovered numerous manufacturing and quality control issues.

In mid-October, the European Medicines Agency (EMA) announced increased oversight measures for substances ZHP produces. The EMA also announced that Indian drug maker Aurobindo Pharma will be prohibited from supplying irbesartan in the European Union (EU).

Most recently, 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 US 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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