Firm recalls OTC teething product
This article was originally published in The Tan Sheet
Executive SummaryCastillo Distributor Inc. voluntarily recalls all of its Monell's Teething Cordial products, which are marketed with Spanish language labels as Cordial de Monell para la Denticion. Little Ferry, N.J.-based Castillo April 8 says it initiated the recall as a precautionary measure due to an increase in adverse event reports, including infant lethargy, possibly linked to the liquid pain-relief products. The nationwide recall includes 4,100 units
You may also be interested in...
FDA’s food, dietary supplement and cosmetics division seeks funding to support its artificial intelligence capabilities, including post-market surveillance and speedy interventions in instances where safety issues arise. Also of note, the agency cites UV filters’ effects on the skin microbiome as a research priority in its fiscal 2021 budget justification to Congress.
Catering to patients can help make clinical trials more accessible and useful, presenters argued at a recent conference.
In separate warning letters, the US FDA says Biomedix (a maker of I.V. administration sets) and Unetixs Vascular (a maker of vascular diagnostic ultrasound systems) must hire outside consultants to review their quality systems after serious deficiencies were noted by agency investigators. A total of three enforcement missives were released by the FDA this week.