Acting on orders from the FDA, federal marshals siezed a quantity of ultrasound transmission gel from its New Jersey manufacturer after the product was found to have been tainted with dangerous bacteria.
The Newark-based Pharmaceutical Innovations, Inc., makers of Other-Sonic Generic Ultrasound Transmission Gel, previously had run afoul of the federal government in July 2011, when the company was warned that its failure to produce a sterile product would lead to bigger problems.
“Specifically, your Ultra Phonic Conductivity Gel, lot # 100110, was released to the market as a sterile product; however, your firm failed to establish and maintain documented procedures for final inspection and testing activities in order to verify that the specified sterility requirements for the Ultra Phonic Conductivity Gel were met,” reads the complaint from last summer.
"This ultrasound gel presented serious health risks to patients, particularly vulnerable ones," said Dara A. Corrigan, FDA associate commissioner for regulatory affairs in a statement. "Therefore, FDA, with the assistance of our state partner, is taking aggressive enforcement action to protect the public health."
In a statement attributed to Pharmaceutical Innovations president Gilbert Buchhalter, the company asserted that it never intended the gel to be sold as a sterile product, and that it had alerted its customers that it would recall any products affected by the batch.
"When Pharmaceutical Innovations learned of misuse of these products, and the discovered contamination, all distributors were advised to suspend distribution and return affected lots to the company," Buchhalter's statement reads. "The Company believes that the remedial (sic) actions it has taken are sufficient."