- Mylan has voluntarily recalled 277,267 bottles of a generic high blood pressure drug, which it manufactures for Novartis' Sandoz unit in India.
- The generics drugmaker issues the recall because of failed impurities and degradation specifications at the 9-month stability point of candesartan cilexetil, according to the recall notice.
- This is part of a much larger problem. Last year, Mylan received a warning letter from the FDA regarding three of its plants where sterile injectable drugs are manufactured.
If Mylan was hoping this year would be a turnaround from the previous two in terms of its compliance issues in India, their hopes have been dashed.
In October 2014, Sandoz had to issue a similar recall, then of only 6,336 bottles of candesartan. Subsequently, Mylan started to experience problems at plants it had purchased from Strides Arcolab several years ago in a $1.75 billion deal. It recalled a number of cancer drugs, including some marketed by Pfizer.
Although Strides contributed $150 million under the terms of the deal to manage compliance contingencies, Mylan has asked for more money to cover its ongoing struggles to meet FDA specifications.