FDA Slaps Class I Label On Recall Of Eco-Med Ultrasound Gels, Lotions
Now-defunct Canadian manufacturer Eco-Med Pharmaceutical Inc. initiated the recall of its gels and lotions – sold under an array of product names – because there’s a chance they could be contaminated with harmful bacteria.
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The agency is asking health care providers to dispose of all ultrasound gels and lotions from the defunct Canadian manufacturer after learning that manufacturing problems may have brought on bacterial contamination.
Device makers presented with an affidavit by the US FDA during a facility inspection should walk away as quickly as possible, King & Spalding partner Jessica Ringel advises.
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