Amneal Using Unapproved Color Additives in Drugs: FDA

FDA says Amneal Pharmaceuticals of New York, in Brookhaven, NY, has been using unapproved Red #2 and Red #3 color additives in the manufacturing of prescription drugs. A just-released 10/27 Notice of Violation says the agency found the violations in its review of Amneal records that FDA requested on 4/24.

The letter says Amneal’s dexmethylphenidate HCL extended-release capsules are adulterated by containing the Red #2 additive. The records also showed that Amneal manufactured additional drug products that contained Red #3, it says.

The agency acknowledges Amneal’s action in suspending manufacturing and distribution of its dexmethylphenidate product and to reformulate the product and also reformulate the drugs that contain Red #3.

The notice tells Amneal to address the violations promptly and to ensure that appropriate resources are allocated to fully address the violations and prevent their recurrence.