Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

Topics

Related Companies

UsernamePublicRestriction

Register

LL1135972

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel