Top of mind for Mylan ($MYL) may be fending off an unsolicited $40 billion buyout offer from competitor Teva ($TEVA) even as it is being rebuffed for making its own $31 billion bid for Perrigo ($PRGO), but it still has to take care of business as usual. Right now that includes having to recall 8 lots of injectable cancer drugs, most of it manufactured for Pfizer ($PFE), after particulate was discovered in vials.
The voluntary recall includes one lot of carboplatin with a Mylan label. The rest of the recall, including 5 lots of gemcitabine in different doses, and one lot each of methotrexate and cytarabine were shipped with Pfizer labels. While there have been no adverse events reported, Mylan pointed out that particulate carries risks if patients are injected with it.
The drugs were all packaged in Agila Onco plants, which Mylan got as part of a $1.75 billion buyout of the sterile injectables business of India's Strides Arcolab in 2012 after deciding it wanted to be a big deal in that part of the market. While Mylan did not specify from which plants most of the drugs were manufactured, it did say that the cytarabine was manufactured by an Agila plant in Bangalore. That plant was issued an FDA warning letter in 2013, shortly before Mylan closed the deal for Agila Specialities. The FDA chastised the Indian plant for using defective gloves in the aseptic processing area and then not taking the problems seriously enough.
Mylan last year had to recall another drug manufactured for Pfizer in an Agila plant. In that case, it was 10 lots of the injectable "hypnotic drug" etomidate. Mylan said at the time that the cartons and the vials may be missing lot numbers and expiry dates or they may be illegible on the vials. The vials may also have black particulate in them, which the company said was identified as paper shipper labels. While Mylan is making some sterile injectables for Pfizer now, Pfizer is in the process of buying sterile injectable specialist Hospira ($HSP) in a $15 billion deal.
Meanwhile, in a series of chesslike moves this month, Mylan made a $29 billion offer for generic and over-the-counter specialist Perrigo, which Perrigo rejected. Teva then made a $40 billion offer for Mylan. Teva said its offer was contingent on Mylan not completing the Perrigo deal. Mylan promptly rejected the Teva offer and then turned around and upped its bid for Perrigo to about $31 billion, which Perrigo again rejected.
- here's the recall notice