Ethex recalls three lots of dextroamphetamine tablets
This article was originally published in Scrip
Executive Summary
KV Pharmaceutical's Ethex generics division has recalled three lots of dextroamphetamine 5mg tablets owing to the possible presence of oversized tablets which may contain twice the labelled amount of active ingredient. The recalled lots were distributed under the Ethex label between January 2007 and May 2008. The company said it found a small number of oversized tablets in lots that had not yet been distributed. There have been no reports from wholesalers, retailers or consumers about oversized tablets and no reports of unexpected side effects or injuries.
You may also be interested in...
US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios
Forthcoming guidance is expected to describe areas of “low-hanging fruit” and those that are more challenging for use of the expedited pathway, Center for Biologics Evaluation and Research Director Peter Marks said.
Puberty Blockers: FDA's Califf Asked If REMS, Boxed Warning Against Off-Label Use In The Works
FDA Commissioner Robert Califf tells House appropriations subcommittee chair the agency will 'consider any information that may be available' on off-label use of puberty blockers for gender dysphoria before making a regulatory decision.
ADHD Drugs: FDA Commissioner Blames Inappropriate Prescribing For Shortages
ADHD drug shortages may have resulted from industry reticence to fill DEA quotas, as well as a 'heavy element of professional responsibility' with off-label prescribing, Robert Califf told a House appropriations subcommittee.