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Six years after an embarrassing episode came to light, Dr. Reddy’s Laboratories has agreed to pay a $5 million fine for knowingly distributing medicines in blister packs that were not child resistant as required by federal law.

In disclosing the settlement, the U.S. Department of Justice noted that packaging engineers at the company’s subsidiary in New Jersey prepared a report in 2011 detailing how child-resistant blister packs for several medicines did not meet federal standards. Despite being urged by its own employees to test the packaging, the company shipped the generic medicines anyway, according to court documents.


The shipments first became publicly known in 2016, when the U.S. Consumer Product Safety Commission sought civil penalties against Dr. Reddy’s, which is one of the world’s largest generic drug makers. At the time, the company reported the violations occurred between 2002 and 2011, although these were contained in a whistleblower lawsuit filed in 2012 by two former employees.

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