Morton Grove Pharmaceuticals, Illicit Drug Manufacturing, Illinois 2023

Adulterated Drugs, Nationwide: A federal court has ordered Morton Grove Pharmaceuticals Inc. to cease manufacturing and distributing drugs alleged to be adulterated in violation of the Federal Food, Drug, and Cosmetic Act (FDCA).

According to a civil complaint filed on August 17, Morton Grove Pharmaceuticals allegedly violated the FDCA at its facility in Morton Grove, Illinois by manufacturing and distributing adulterated drugs. The company, which makes and distributes prescription and over-the-counter drugs, such as cough syrups and nasal sprays, failed to have adequate procedures to prevent cross-contamination of equipment, failed to reject drug lots using a contaminated ingredient, and failed to fully investigate the root cause of such contamination, the complaint stated.

The FDA inspected the company’s facility five times, in 2011, 2014, 2016, 2019, and 2021, and many of the violations were repeat violations the FDA had identified in earlier inspections. The current good manufacturing practice regulations mandate that manufacturers control the processes and procedures by which drugs are manufactured, processed, packed, and held, to ensure that drugs have the identity, strength, quality, purity, and other attributes necessary for their safe and effective use.

Drugs not made in conformance with current good manufacturing practice regulations are adulterated and in violation of the law. According to the Justice Department’s complaint, the FDA issued Morton Grove Pharmaceuticals several warnings, including a warning letter to the company in 2017, regarding alleged deficiencies at its facility.

“Drug manufacturers have an important responsibility to ensure drug quality and safety,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Justice Department will continue to work closely with the FDA and take action against manufacturers who fail to abide by laws designed to protect public health.”

Morton Grove Pharmaceuticals agreed to settle the suit and be bound by a consent decree of permanent injunction. The negotiated consent decree entered by the court permanently enjoins the defendants from violating the FDCA, and requires, among other things, that the defendants stop manufacturing, processing, labeling, holding, or distributing adulterated drugs. Further, the defendants must destroy all drugs in the facility, except for those that are medically necessary.

The defendants agreed to settle the suit. The consent decree was not available for public inspection. The case was prosecuted by Senior Litigation Counsels Donald Lorenzen and Christina Parascandola of the Civil Division’s Consumer Protection Branch.

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