Mylan ($MYL) is experiencing more problems with its manufacturing in India, leading to the recall of more than 277,000 bottles of a high blood pressure med that the generics maker produces for Sandoz, the generics arm of Novartis' ($NVS). The recall comes just over a year after Mylan had issues with the same Sandoz med for the same problem.
According to the FDA's most recent Enforcement Report, Sandoz is voluntarily recalling 15 lots, comprising 277,267 bottles of candesartan cilexetil tablets that were manufactured by Mylan in India. The posting says that they failed impurities and degradation specifications at the 9-month stability time point.
In October of 2014, Sandoz voluntarily recalled 6,336 bottles of candesartan cilexetil after testing at 18 months found the drug contained more impurities than specification allows.
A more overriding problem for Mylan's manufacturing in India has been dealing with issues cited in an FDA warning letter last year of three of its plants there where it manufactures sterile injectable drugs. Mylan recalled cancer drugs, some produced for Pfizer ($PFE), after the FDA pointed out problems during its inspection. Mylan bought those plants several years ago in a $1.75 billion acquisition of the sterile injectables business of what was then Strides Arcolab.
Mylan in 2014 collected $150 million in contingency fees from Strides to cover a portion of the costs related to fixing the problems. But in December, Strides acknowledged that Mylan was asking for more. Strides said it still had $200 million in escrow to cover any additional payments if required.
- here's the recall notice