Generic drug producer Mylan ($MYL) has had some manufacturing issues of late that have resulted in recalls of cancer drugs made for Pfizer ($PFE). Now it finds itself in the reverse situation. Mayne Pharma is recalling more than 74,000 bottles of a topical pain drug used in cataract surgeries that it manufactured but which is licensed to and sold by Mylan.
According to the most recent FDA Enforcement Report, Mayne Pharma is recalling 74,108 bottles of Bromfenac Ophthalmic Solution 0.09%, a sterile, topical, nonsteroidal anti-inflammatory drug, because it failed preservative effectiveness testing.
This recall follows one last summer when Mylan retrieved a number of lots of cancer meds gemcitabine, methotrexate, and carboplatin, some of them manufactured for Pfizer, after the FDA raised questions about sterility issues. In that case, the recalls were a precursor to a warning letter the FDA posted in August for three of Mylan's Agila specialties plants in Bangalore that raised serious concerns about contamination.
Australia-based Mayne, for its part, is expanding its own drugmaking capabilities in the U.S. with a $65 million, 126,000-square-foot oral-dose facility in Greenville, NC, next to the facility it already has there.
- here's the announcement
Editors Note: This story was updated to point out the recalled medication was manufactured by Mayne Pharma.