FDA Stops Short Of Opiates Recall After Product Mix-Up At Novartis Plant
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency issued a public health advisory warning pharmacists and patients to inspect bottles of opiate products made at the plant, including Endo’s Percocet and Percodan, for improper pills; an FDA official says the risk-benefit analysis is different for Novartis OTC products, which were voluntarily recalled.
You may also be interested in...
Sandoz GMP Warning Letter: Is The Problem Documentation, Or Leadership?
Upper management at Novartis and Sandoz are responsible for repeated cGMP violations at three Sandoz plants, FDA suggests. The agency’s warning letter, aimed at three sites in North Amercia, includes what may become new biolerplate instructions on drug shortages.
A Visual Guide To How FDA Can Manage The Pandemic
Our infographic illustrates the recommendations in FDA’s COVID-19 pandemic recovery and preparedness plan, ranging from strengthening the EUA process to managing the backlog of pending inspections.
Permanent Vaccine Facility Should Be On Standby For Future Pandemics, Moncef Slaoui Says
Operation Warp Speed confirmed the necessity of having a facility on hand to develop and manufacture a vaccine for the next crisis, the outgoing advisor says.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: