On Friday, an Illinois pharmaceutical manufacturer was ordered to stop making and selling adulterated drugs. The company was also ordered to destroy all drugs in the factory not deemed medically necessary.
Morton Grove Pharmaceuticals manufactures prescription and over-the-counter drugs, including cough syrup and nasal spray. The company is a subsidiary of Wockhardt, an Indian company.
According to the Department of Justice, the company violated the Federal Food, Drug and Cosmetic Act by failing to prevent cross-contamination, failing to reject contaminated drug lots and failing to investigate the root cause of the contamination.
The injunction comes after the company was inspected and warned by the FDA multiple times after repeated violations. The FDA inspected the facility in 2011, 2014, 2016, 2019 and 2021. The FDA also issued Morton Grove Pharmaceuticals several warnings, including a warning letter to the company in 2017, regarding problems at the facility.
Morton Grove Pharmaceuticals, and president Gopalakrishnan Venkatesan, agreed to settle the suit. As a result, Wockhardt is closing its manufacturing facility in Morton Grove, Illinois, its lone American factory, and will pursue U.S. business using contract manufacturers to make products sold in North America. The company will also sell off the property.
Current good manufacturing practice regulations force manufacturers to control drug manufacturing processes and procedures to ensure that drugs have the strength, quality and purity for safe and effective use. Drugs that don't conform with current good manufacturing practice regulations are not only considered adulterated, but in violation of the law and put the public at risk.
The company has 60 days to destroy all drugs in the facility except for those deemed medically necessary. To be "medically necessary," the drugs need to treat serious diseases or medical conditions, or be unavailable from another manufacturer. Morton Grove makes three medically necessary drugs, including carbamazepine oral suspension (an anti-epileptic), dexamethasone elixir (used to treat various conditions, from arthritis to bowel disorders) and megestrol acetate oral suspension (treats severe weight loss and malnutrition in AIDS patients).
According to the Hindu Business Line, the closure won't affect product availability in the U.S. Wockhardt's still operates seven plants in India, one in the UK and another in Ireland.