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news.The Food and Drug Administration (FDA) has given a verdict against Deltex Pharmaceuticals on the basis of significant violations, including manufacturing and distributing unapproved, adulterated and misbranded drugs.
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Originally, the FDA has requested a permanent injunction against Deltex and its president Kabir Ahmed and vice president Mohidur Khan, as the company allegedly failed to obtain approval for its prescription drugs, failed to comply with federal regulations governing over-the-counter drugs and did not adhere to good manufacturing practices.
Deltex Pharma expects to call off and destroy all its drugs produced and distributed since 31 Oct 2008 and inform customers of the recall.
Ahmed said Deltex has and will continue to take all the necessary steps to comport with (manufacturing) requirements and pass FDA inspection.
"In addition, Deltex has for some time discontinued manufacture and distribution of those drugs which the FDA has deemed unapproved new drugs," Ahmed said.