The FDA has issued on update on Eco-Med Pharmaceutical’s Aug. 4 recall of its ultrasound gels and lotions, deeming it a Class 1 recall because of the risk of serious injury or death.

The Ontario, Canada-based company has shut down operations, ceasing to manufacture and distribute the ultrasound gels and lotions due to the risk of bacterial contamination, the FDA said.

The recalled gels and lotions were manufactured and distributed from 2018 until earlier this year. As of Aug. 31, there had been at least 66 infections, including 60 bloodstream infections, associated with the affected products, the agency said.