FDA Alerts to Recalls Over Non-Valsartan Product Found to Contain Impurities

Regulatory NewsRegulatory News | 01 November 2018 |  By 

In its latest update on the investigation into impurities detected in a growing body of sartan products, the US Food and Drug Administration (FDA) alerted to recalls initiated by two firms over the presence of the second probable human carcinogen to have been tied to the scandal.
ScieGen is recalling certain lots of its irbesartan because after finding that they contain N-Nitrosodiethylamine (NDEA), which is known animal and suspected human carcinogen, according to FDA.
“This is the first non-valsartan product the agency has found to contain the NDEA impurity” the agency said, adding that the recall “affects about 1% of the irbesartan drug products in the US market.”
The manufacturer of the active pharmaceutical ingredient (API) ScieGen used for its irbesartan products—India-based Aurobindo—is also recalling “all unexpired lots of its irbesartan API supplied to the US market with NDEA,” FDA said. This recall was initiated after laboratory testing confirmed the presence of NDEA is certain lots of Aurbindo’s irbesartan API, according to FDA.
The updates come after the European Medicines Agency (EMA) announced low levels of NDEA had been detected in Aurobindo’s irbesartan earlier this month. The move came after “very low levels of NDEA” had been detected in losartan products manufactured by the first India-based company to become involved in the scandal, Hetero Labs, prompting EMA to extend its review to cover additional sartan medicines late last month.
EMA is also reviewing candesartan and olmesartan. Neither NDEA nor the first impurity classified as a probable human carcinogen to have been detected in valsartan-containing medicines—N-Nitrosodimethylamine (NDMA)—have been found in these two sartans so far.
The drug safety saga began in July with an EU-wide recall of certain valsartan-containing medicines initiated by EMA in response to the detected presence of NDMA in the valsartan manufactured by China-based Zhejiang Huahai.
Last month, EMA, FDA and Health Canada reported NDEA had also been detected in products containing valsartan supplied by Zhejiang Huahai. EMA previously reported detecting low levels of NDMA by the second China-based company to enter the picture, Zhejiang Tianyu.
EMA issued a statement of noncompliance to Zhejiang Huahai on the same day FDA placed the company on import alert in September. The actions are intended to prevent manufacturer use of the firm’s valsartan and speak to how the regulatory authorities have collaborated throughout the investigations.
EMA’s notice regarding Aurobindo also informed of its decision to place to Zhejiang Huahai under increased supervision “following European and US inspections which revealed weaknesses in quality management at the company’s Chuannan site in Linhai, China.”
FDA has issued several Form 483s to Zhejiang Huahai over the past few years as well as a warning letter to a Hetero Labs branch in 2017.
FDA reminded manufacturers Tuesday “they are responsible for developing and using suitable methods to detect impurities, including when they make changes to their manufacturing processes.”  It noted that “if a manufacturer detects new or higher levels of impurities, they should fully evaluate the impurities and take action to ensure the product is safe for patients.”


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