HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Clear Eyes Recall Adds Clarity To Extent Of Impact From Altaire Sterility Concerns

Executive Summary

Number of containers recalled varies from nearly 6.7m bottles of Clear Eyes Redness Relief to 1,752 bottles of brand's Maximum Itchy Eye Relief. Updates to FDA database also include recalls of private label/store brand OTCs as agency finds more problems at manufacturers providing drugs for drug store chains, other retailers and distributors.

You may also be interested in...



Bacteria Linked To Unipharma Recall In August Identified By FDA In April

FDA says in warning letter that Unipharma was in violation of labeling rules for OTC nasal sprays as well as being non-compliant with drug GMP requirements for documenting adherence to specifications.

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.

US FDA Regulatory Roundup: Ceba-Tek GMP Warning, Altaire Expands Recall

GMP violations FDA warned Ceba-Tek about following an inspection in January and February include problems agency officials also noted in 2014 and 2015; Altaire Pharmaceuticals recalls of ophthalmic products due to lack of sterility assurance passes 500 lots, including 28 of Clear Eyes announced July 16.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

RS149154

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