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


FDA Pressure Likely In Novartis OTC Plant Shutdown, Recalls

This article was originally published in The Tan Sheet

Executive Summary

FDA inspectors were in Novartis Consumer Health’s Lincoln, Neb., plant in December and January, as the company was deciding to halt production and recall products. An inspection report notes 10 observations – eight of them repeats from FDA’s visit in mid-2011.

You may also be interested in...

Novartis Opts For OTC Recall, With J&J/McNeil Lessons Still Fresh

After shuttering its Lincoln, Neb., OTC facility, the firm recalls some lots of Bufferin, Excedrin, Gas-X and NoDoz. FDA found a “pattern of problems” when inspecting the plant in 2011, and Novartis’ actions suggest it seeks to avoid the same scrutiny that Johnson & Johnson’s OTC recalls elicited.

Perrigo Takes Two Steps Forward: Generic Allegra Launch, Manufacturing Compliance

Perrigo stokes momentum behind already healthy sales growth with significant steps in separate areas: a green light for regulatory compliance at its main manufacturing plant, and the launch of its generic OTC versions of Sanofi-Aventis' Allegra.

Andrx Concerta

Firm has pending ANDAs for generic versions of McNeil's Rx Concerta (methylphenidare hydrochloride) extended-release tablets in 18, 27, 36 and 54 mg formulations. McNeil's exclusivity for the pediatric hyperactivity deficit disorder drug was set to expire March 17, and the firm has filed a citizen petition with FDA "that affects the timing of, and potentially the approval criteria for, ANDA approvals relating to generic Concerta," according to Andrx. McNeil put 300 sales reps behind the drug in 2000 (1"The Tan Sheet," April 24, 2000, In Brief)...

Related Content


Related Companies

Latest Headlines
See All



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