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# Device Maker Pleads Guilty On Contaminated Ultrasound Gel
- URL: https://www.fdaweb.com/device-maker-pleads-guilty-on-contaminated-ultrasound-gel/
- Published: 2016-07-11T12:00:00.000Z
- Updated: 2026-09-14T21:13:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136126

Newark, NJ-based Pharmaceutical Innovations has pleaded guilty to criminal charges and resolved a civil lawsuit surrounding its distribution of ultrasound gel contaminated with bacteria. The company pleaded guilty in Newark federal court to an information charging it with two misdemeanor counts of introducing adulterated medical devices into interstate commerce, according to a Justice Department [release](https://www.justice.gov/opa/pr/new-jersey-medical-device-manufacturer-admits-selling-contaminated-ultrasound-gel-court?ref=fdaweb.com). In addition to entering into a two-year probation, the company must pay a criminal fine of $50,000 and forfeit $50,000, the government says.

In the civil settlement, Pharmaceutical Innovations agreed to forfeit and destroy certain gel products that tested exceptionally high for infectious bacteria and agreed to a permanent injunction that requires independent experts and auditors to conduct regular inspections and certifications at the company’s expense.

According to documents filed in the case, a Michigan hospital reported in 2012 that 16 surgical patients were infected with *Pseudomonas aeruginosa*, a bacterial pathogen. The hospital believed the infections were associated with a particular lot of Pharmaceutical Innovations ultrasound gel. A lot sample subsequently tested positive for the bacteria. A second lot was shipped and later found to be contaminated with two types of bacteria, *Pseudomonas aeruginosa* and *Klebsiella oxytoca*, both at the Michigan hospital, and at the Newark manufacturing facility.

A consent decree entered as part of the settlement requires Pharmaceutical Innovations to submit a detailed compliance plan to FDA within 20 days, and to have outside experts certify in writing by 10/31 that it meets current good manufacturing practice requirements.