Sterile injectable drugs are a growth area, but they are notoriously tricky to manufacture. Mylan has found that out the hard way and is having to expand a recall of cancer drugs that it began in April because they may contain particulate. Some of the drugs were manufactured for Pfizer ($PFE).
The FDA Monday circulated a Mylan ($MYL) press release that said the company is recalling 7 lots of the cancer med gemcitabine, which is used to treat ovarian, breast, pancreatic and non-small cell lung cancers. Two of those lots have a Pfizer label. It also is recalling one lot of methotrexate, which is used to treat certain neoplastic diseases, severe psoriasis and adult rheumatoid arthritis.
In the initial recall, Mylan recalled one lot of the cancer drug carboplatin with a Mylan label. It also recalled 7 lots of oncology meds it manufactured for Pfizer. Those included 5 lots of gemcitabine in different doses, and one lot each of methotrexate and cytarabine. Mylan said there have been no reports of adverse reactions but cautioned that there is a range of dangers posed if particulate gets injected into a patient. Some of the risks, like the chance of stroke, are severe.
The drugs were all packaged in Agila Onco plants. Mylan acquired those in 2013 in its $1.75 billion buyout of the sterile injectables business of India's Strides Arcolab, a deal it made to become a significant player in the sterile injectables business. Mylan said in April that cytarabine it made for Pfizer had come from its Agila plant in Bangalore, a facility that had been cited with a warning letter by the FDA in 2013, shortly before Mylan closed the deal for Agila Specialties. The FDA cited the Indian plant for using defective gloves in the aseptic processing area and then not taking the problems seriously enough.
Mylan has had to recall drugs made for Pfizer at one of its Agila plants before. Last year, it retrieved 10 lots of the injectable "hypnotic drug" etomidate because some of the cartons and vials were missing shipping labels. There was also black particulate in some vials that was identified as coming from shredded labels.
Pfizer is making its own move to expand its sterile injectables business. This year, it struck a $17 billion buyout deal with Hospira ($HSP), a company that has often had to recall products. In fact, according to the most recent FDA Enforcement Report, Hospira is is currently recalling nearly 25,000 bags of lactated ringer's irrigation because of sterility concerns after a customer discovered what Hospira identified as mold floating in one.