On October 3, 2014, the U.S. Food and Drug Administration announced that it is seeking a permanent injunction to stop Pharmaceutical Innovations Inc., and its principal officer, Gilbert Buchalter, from manufacturing, marketing, selling, and distributing any medical products until those products come into compliance with all applicable FDA requirements.
Pharmaceutical Innovations Inc. is a Newark, New Jersey-based medical device firm that manufactures ultrasound, mammography, and electrocardiogram gels, and scanning pads. The devices are used for diagnostic purposes in the health care environments.
The complaint for permanent injunction was filed by the U.S. Department of Justice on behalf of the FDA on October 2, 2014, in the U.S. District Court for the District of New Jersey.
Complaint allegations include that Pharmaceutical Innovations Inc. did not conform with current good manufacturing practice requirements, as mandated under the Federal Food, Drug, and Cosmetic Act, when they manufactured their devices. The complaint also alleges that the firm distributed its products nationwide without required pre-market approval or clearance.
Also included in the complaint are details concerning the United States marshals, who were acting on a request by the FDA. The marshals seized specific lots of Other-Sonic Generic Ultrasound Transmission Gel in April 2012. The seizure occurred after the agency’s laboratories discovered a significant amount of Pseudomonas aeruginosa and Klebsiella oxytoca in these lots.
These bacteria present significant infection risks, including pneumonia, to exposed individuals. In fact, the agency is aware of people infected with Pseudomonas aeruginosa following surgical procedures that took place at one Michigan hospital and that involved Pharmaceutical Innovations Inc.’s “Other-Sonic Generic Ultrasound Transmission Gel.”
The agency issued a safety alert to the health care community on April 18, 2012, advising use of the contaminated product be ceased. Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs noted that, “Despite multiple warnings by the FDA over the past three years, and promises to correct the numerous ongoing violations, the defendants continued to violate the law.” She added that, “This presents serious health risks to patients who used and continue to use the company’s products.”
A prior recall on the “Other-Sonic Generic Ultrasound Transmission Gel” was deemed a Class I in 2012 by the FDA. A Class I recall designation involves a situation in which there exists a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
“Other-Sonic Generic Ultrasound Transmission Gel” is a non-sterile gel utilized in ultrasound procedures for the purpose of improving the transmission and receipt of ultrasound waves. Although this product is not labeled as either sterile or non-sterile, it is NOT sterile.