NEW YORK – The U.S. Department of Justice has imposed a $5 million civil penalty and entered a consent decree of permanent injunction against the U.S. branch of the Indian company Dr. Reddy’s Laboratories for failing to obey the Poison Prevention Packaging Act (PPPA) and the Consumer Product Safety Act (CPSA), according to The Pharmaletter.
According to The Pharmaletter, the Justice Department filed a complaint in the District of New Jersey on Dec. 18, 2017 on behalf of the Consumer Product Safety Commission, which alleged that Dr. Reddy’s Laboratories continued to distribute household oral prescription drugs, until 2012, in blister packs that were not child resistant and were expected to fail the PPPA’s child test protocol, even when they were warned by their own employees.
The complaint further states that “Dr. Reddy’s failed to notify the CPSC ‘immediately,’ as required by law, that its products were not compliant with the PPPA, that the products contained a defect presenting a substantial product hazard, and that the products created an unreasonable risk of serious injury or death.”
In addition to the $5 million civil penalty, the consent decree prohibits Dr. Reddy’s Laboratories from distributing household oral prescription drugs that are in violation of the PPPA and CPSA and requires Dr. Reddy’s to implement a compliance program, according to The Pharmaletter.
The injunction further requires Dr. Reddy’s to maintain internal controls and procedures designed to ensure timely, truthful, complete, and accurate reporting to the CPSC as required by law.
Though agreeing to the settlement, Dr. Reddy’s has not admitted that it violated the law.