FDA Stops Short Of Opiates Recall After Product Mix-Up At Novartis Plant
This article was originally published in The Pink Sheet Daily
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...
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.
FDA concluded that original formulation of brain hemorrhage treatment was not discontinued for safety or effectiveness reasons, saying Arbor had other options to reduce risk of confusion between the new and original formulations. But the sponsor argues that withdrawal was part of FDA-approved risk mitigation plan.
The agency's "Bad Ad" program issued a warning letter that claims the promotion for CooperSurgical's copper-containing intrauterine contraceptive lacked any safety information.