For the second time in less than a year, the Food and Drug Administration has warned Mylan (MYL) over a failure to maintain standards at plants that manufacture active pharmaceutical ingredients.
In an Aug. 20 warning letter, the agency admonished the big generic drug maker for not ensuring adequate cleaning procedures to prevent contamination and failing to assess the risks that impurities would find their way into solvents. The infractions occurred this past February at a plant in India.
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One might observe that it is surely coincidence that this item was also posted by CDER on the same day as this letter.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-initiates-voluntary-nationwide-recall-four-lots-amiodarone-hcl-injection-usp-and-tranexamic