Dr. Reddy's Laboratories was fined $5 million for allegedly violating federal law by distributing household oral prescription drugs in blister packs that were not child resistant, according to the Department of Justice.
In addition to imposing the civil penalty, a New Jersey federal court also entered a permanent injunction against the drugmaker.
The case stems from a complaint filed by the federal government in the District of New Jersey Dec. 18. In the complaint, the federal government alleges Dr. Reddy's violated the Consumer Product Safety Act when it distributed prescription drugs in packaging that was not child resistant per Poison Prevention Packaging Act requirements, according to the DOJ. The federal government alleges Dr. Reddy's employees warned the drugmaker packaging had not been tested for compliance with the PPPA and that some of the packaging was expected to be noncompliant, but Dr. Reddy's still distributed the drugs until 2012.
The DOJ said Dr. Reddy's also allegedly did not "immediately" notify the CPSC per federal law of the PPPA noncompliance related to its products, or that the products "contained a defect presenting a substantial product hazard" and "created an unreasonable risk of serious injury or death."
"The complaint further asserts that Dr. Reddy's failed to certify that its products were in conformance with the PPPA," according to the DOJ.
Although Dr. Reddy's agreed to the settlement, the drugmaker has not admitted guilt. Under the permanent injunction, Dr. Reddy's may not distribute household oral prescription drugs in violation of the PPPA and CPSA, and must implement a compliance program, according to the DOJ. The drugmaker must also "maintain internal controls and procedures designed to ensure timely, truthful, complete and accurate reporting to the CPSC as required by law."
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