Particle.news
Download on the App Store

Recall Issued for Three Napralief Batches Over Missing Dosing and Safety Information

Regulators say the painkiller remains safe at the correct dose.

Overview

  • Omega Pharma, which announced the recall Thursday, is withdrawing Napralief 250mg batches B51496, B51497 and B51102 after key instructions were left off the carton and patient leaflet.
  • The missing details include the warning not to take more than three tablets in a day, which is meant to prevent accidental overuse.
  • MHRA guidance tells patients to take two tablets on day one, then one tablet 6–8 hours later, and on days two and three one tablet every 6–8 hours if needed, for no more than three days.
  • Other absent safety advice covers eye checks for new vision problems, the risk of severe allergic reactions, information about certain heart and autoimmune conditions and serious skin reactions, and stopping treatment 48 hours before some blood or urine tests.
  • Healthcare professionals have been told to stop supplying the affected stock and return it, while patients who notice side effects should seek medical advice and report them via the MHRA Yellow Card scheme.