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.
Arbor Emphasizes Risks Of Its Own Product In Suit Against US FDA To Block Nymalize Generics
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.
CooperSurgical Lands US FDA Warning Letter Over ParaGuard TV Spot
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.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: