Scrip 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

Ethex extends recall of oversized tablets

This article was originally published in Scrip

Executive Summary

KV Pharmaceutical's Ethex generics division has expanded its recall of medicines that may contain oversized tablets with twice the intended level of active ingredient. Last month the company recalled three lots of dextroamphetamine 5mg tablets. The recall has now been extended to multiple lots of propafenone HCl 150mg, 225mg, and 300mg tablets; isosorbide mononitrate extended-release 30mg and 60mg tablets; morphine sulphate extended-release 15mg tablets; morphine sulphate immediate-release 15mg and 30mg tablets; and dextroamphetamine sulfate 10mg tablets. The products are being recalled to the consumer level, and Ethex is instructing pharmacies to contact consumers who were dispensed the drugs for replacement and/or refund.

You may also be interested in...



CDER Planning Guidances On Single-Trial Approvals, Real-World Evidence

US FDA drugs center’s ambitious guidance agenda lists 105 new or revised guidances, most of which carried over from the prior year; new to the list are three guidances each on real-world data and individualized antisense oligonucleotide drug products, and a document focused on demonstrating efficacy with a single adequate and well-controlled trial.

Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA

AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.

2020 In Review: US FDA New Drug Office’s COVID-19 Response Aided By Reorganization

Office of New Drugs Director Peter Stein tells the Pink Sheet that last phase of massive reorg was complicated by pandemic restrictions that forced review staff to work remotely, but the structural overhaul resulted in smaller, more nimble review groups and the breaking down of silos that ultimately helped the agency’s response to the public health crisis.

UsernamePublicRestriction

Register

OM004634

Ask The Analyst

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

Thank you for submitting your question. We will respond to you within 2 business days. 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