The U.S. Department of Justice has filed a lawsuit to keep a Tinton Falls-based drug compounding business closed three months after mold was discovered in five intravenous bags it had prepared for a hospital.
The complaint against Med Prep Consulting and its owner, Gerald Tighe, cited numerous health violations, drug misbranding and years of repeated failures to comply with warnings as evidence of wrongdoing. The lawsuit, on behalf of the Food and Drug Administration, was filed Friday in federal court in Trenton.
The government is seeking an injunction to keep Med Prep closed permanently unless the company can prove it has complied with health and safety guidelines under the Federal Food, Drug, and Cosmetic Act. According to the lawsuit, FDA violations against Med Prep date to 2009. “Despite these warnings, defendants’ violations have persisted,” the lawsuit said.
Med Prep has remained shut since issuing a nationwide recall of all its drugs following discovery of contaminated bags of magnesium sulfate that were compounded and dispensed to a Connecticut hospital. The recall included dozens of drugs packaged in infusion bags, plastic syringes and glass vials distributed to 70 hospital and health care facilities throughout New Jersey, Pennsylvania, Connecticut and Delaware.