Mylan expands recalls from plants spanked in FDA warning letter

Just days after the FDA hammered Mylan ($MYL) sterile injectable plants in India in a warning letter, the drugmaker has said it is expanding a recall of injected cancer meds it manufactures there for Pfizer ($PFE).

Mylan CEO Heather Bresch

According to the FDA's most recent Enforcement Report, Mylan has added two lots of methotrexate injection and one lot of cytarabine injection, both distributed by Pfizer, to the 15 lots of cancer products it has already recalled. Again, the recall says that particulate matter was found in retained samples. The drugs were all manufactured at plants in India that the FDA cited in warning letter for a boatload of lapses. The warning letter was posted Tuesday to an FDA site.

The FDA citation for the three plants in Bangalore said investigators found a variety of problems that could lead to product contamination. It pointed out Mylan's quality control management had not gotten on top of problems even though one of the plants had been cited in an earlier warning letter just ahead of Mylan closing its deal to buy the Agila Specialties operations from Strides.

The FDA said the company had failed to investigate consumer complaints thoroughly and pointed out it was only in response to the inspection that one of the plants discovered the "foreign particulate matter" in lots of gemcitabine, carboplatin, methotrexate and cytarabine, cancer meds manufactured at the sites, including the drugs it produced for Pfizer. The agency acknowledged Mylan's intent to fix the issues, but said until it does, it will not accept any applications for new or generic drugs from the three facilities.

The matter was serious enough that Mylan CEO Heather Bresch issued a statement assuring investors and the public that Mylan has "a deep and unwavering commitment to quality" and is working diligently to address the FDA concerns. The embarrassment level from the the warning letter is intensified by the fact that Mylan is in the midst of a takeover attempt for Perrigo ($PRGO) that the consumer drug specialist has not received with open arms.

- the recall notices are here and here

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