HBW Insight 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

Testing Ranitidine With Too Much Heat Could Generate NDMA, FDA Says

Executive Summary

FDA recommends using "Liquid Chromatography-High Resolution Mass Spectrometry Method" for testing ranitidine rather than method apparently used by online pharmacy Valisure, which asked agency to halt production and order recalls.

You may also be interested in...



HBW Market Roundup: Expo West Postponed, FDA Needs International Cosmetics Meeting Input, More

New Hope Network postponed Natural Products Expo West trade show due to coronavirus; NPA supports Accurate Labels Act; American Health Packaging recalls OTC ranitidine; and FDA seeks input on topics for upcoming International Cooperation on Cosmetics Regulation meeting.

US Health Market In 2019: Unfinished Business Leaves Lasting Impression

Examples of unfinished business from 2019 include no legislation passed to reform OTC monograph program; FDA putting off until May the planned publication of an NPRM to allow firms to submit OTC NDAs with extra-label information to help guide consumers' self-selection; and no OTC naloxone for opioid overdose approved even after FDA's unprecedented step of developing model DFLs sponsors could use for their own label comprehension studies.

More Ranitidine Products, Altaire Eye Drops Among Recent OTC Recalls

Recent updates to FDA recalls database also include single lots of three package sizes of Johnson’s Baby Powder after testing found sub-trace levels of chrysotile asbestos contamination and 5,720 bottles of homeopathic OTCs made in India for West Virginia firm Washington Homeopathic Products Inc. at a facility noncompliant with the agency’s good manufacturing practices regulations.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

RS149272

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