Amgen has recalled select lots of its heart medication Corlanor and kidney disease treatment Sensipar because of foreign material concerns and current good manufacturing practice deviations.
The recall affects multiple lots of Corlanor (ivabradine) 5 milligram and 7.5 milligram tablets, according to a June 23 FDA enforcement report. The 5 milligram recall covers 934,577 bottles because of the presence of a foreign substance, and the 7.5 milligram tablets were recalled for the same reason.
The recall also includes select lots of Sensipar (cinacalcet) 30 milligram, 60 milligram and 90 milligram tablets because of current good manufacturing practice deviations. The FDA enforcement report lists 9,565 bottles of the 30 milligram strength as affected, while quantities were not reported for the 60 milligram and 90 milligram products.
The FDA classified the recalls as Class II, but Amgen initiated the nationwide voluntary recalls June 4 by notifying customers through a letter. The recalls remain ongoing.
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