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Sandoz Recalls Hypertension Drug Made At Indian Mylan Facility



The generic drug is produced for Sandoz – a division of Novartis – and experienced the same quality issue in 2014.

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February 29, 2016 | by Sarah Massey, M.Sc.

A Mylan-owned pharmaceutical manufacturing facility in India has run into more issues, leading to a voluntary recall of over 277,000 bottles of hypertension medication. The generic drug is produced for Sandoz – a division of Novartis – and experienced the same quality issue in 2014.

An Enforcement Report issued by the US Food and Drug Administration (FDA), states that Sandoz is recalling 15 lots of candesartan cilexetil pills, manufactured at Mylan’s Hyderabad facility. The blood pressure medication failed to pass specifications for levels of impurities and degradation at the 9-month stability testing mark.

Sandoz recalled the same drug in October of 2014, citing higher levels of impurities than is acceptable at the 18 month time-point. While the current recall includes 277,267 bottle of candesartan cilexetil, the 2014 recall involved only 6,336 bottles.

The most recent recall represents the least of Mylan’s issues with FDA compliance. In 2015, the agency submitted a warning letter to Mylan regarding three of its Indian sterile injectable manufacturing plants.

Mylan issued a recall for the affected injectable cancer drugs – some of which were manufactured for Pfizer – following the FDA inspection. Mylan acquired the manufacturing facilities for $1.75 billion from the former sterile injectable company, Strides Arcolab.

In 2014, the generics drugmaker received $150 million in contingency fees from Strides Arcolab, to be used towards fixing the compliance issues identified by the FDA. According to Strides, Mylan requested more from money from them in December, of which the former company said they had $200 million more in the event that additional payments were required.

Keywords: Hypertension, India, Generic Drug


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