Top Leaderboard, Site wide
Left Masthead
October 10, 2015
Truthdig: Drilling Beneath the Headlines
Sign up for Truthdig's Email NewsletterLike Truthdig on FacebookFollow Truthdig on TwitterSubscribe to Truthdig's RSS Feed

Chaos Is the GOP’s New Normal

Primo Levi, Complete

Truthdig Bazaar

The Balloonist

By MacDonald Harris and Philip Pullman

more items

Ear to the Ground
Print this item

Meningitis Outbreak Source Broke the Rules

Posted on Oct 12, 2012
paleololigo (CC BY-SA 2.0)

The compounding pharmacy at the center of a meningitis outbreak that has put 14,000 patients at risk was not following the requirements of its license when it shipped more than 17,000 vials of a contaminated steroid to pain clinics in 23 states, a spokeswoman for the Massachusetts Department of Public Health says.

The company had a license to provide doctors with drugs only on the basis of request. The mass production and shipment of the steroid violated that rule.

All three lots of the contaminated steroid have been recalled and production has been suspended.

—Posted by Alexander Reed Kelly.

MedPage Today:

“This organization chose to apparently violate the licensing regulations under which they were allowed to operate,” [Madeleine] Biondolillo told reporters in a telephone news conference Thursday.

An FDA spokesman, Deborah Autor, JD, told MedPage Today the agency has legal remedies available, including the ability to seize products and to lay criminal charges, but she did not elaborate further.

A 2006 warning letter to the company, charging it was acting more like a drug manufacturing firm than a compounding pharmacy, elicited assurances that patient safety was being protected and that applicable laws and regulations were being obeyed, Autor said.

Read more

More Below the Ad


Square, Site wide

New and Improved Comments

If you have trouble leaving a comment, review this help page. Still having problems? Let us know. If you find yourself moderated, take a moment to review our comment policy.

Right 1, Site wide - BlogAds Premium
Right Skyscraper, Site Wide
Right Internal Skyscraper, Site wide
Right 2, Site wide - Blogads
Join the Liberal Blog Advertising Network

Like Truthdig on Facebook