Monday, October 22, the FDA’s MedWatch system released two lists relative to the fungal meningitis outbreak. The first named customers to which NECC shipped products on or after May 21, 2012, the date presumed to be the earliest a patient may have been injected with NECC’s contaminated epidural steroid. The second list alphebetized that information by customer name and enumerated the products those healthcare facilities received.
“The lists were prepared based on information provided by NECC, and FDA cannot vouch for the completeness or accuracy of the lists,” the advisory said. “Products shipped by NECC may be missing from the list and facility information may be incomplete. Nevertheless, this is the best information we have available.”
The agency removed the lists from its website a short time later, the Detroit News reported the next day.
"FDA has found some technical problems with the list and some of the data are incorrect," FDA press officer Erica Jefferson told reporters.
A Michigan hospital told the Times that it appeared on the FDA’s list but had neither purchased nor used any of the drugs connected to the fungal meningitis outbreak.
“We want to find out why we were on that list," St. John Providence Health System spokesman Brian Taylor said.
Last week, Ohio’s Portsmouth Daily Times reported a similar situation when the FDA provided the CDC a list of 64 Ohio clinics to which NECC shipped products between May 21, 2012, and October 3, 2012, when the compounding pharmacy shut down.
“We did not use that specific epidural steroid product here at SOMC,” said Southern Ohio Medical Center Vice President of Safety Leann Sammons. “The physician that used the epidural procedure used a different product. I don’t even believe it was from NECC.”
Today, the FDA released a new list. The 345-page PDF lists NECC’s customers since May 21, 2012, and the products they received. For the new list, click here.
Related posts:
Information re: NECC Investigation Released, Lot 6 Blamed for Fungal Meningitis Cases in Tennessee
NECC News: Age Is Only a Number in Fungal Meningitis Lawsuits
NECC News: FDA Letter to NECC May Answer Senators' and Consumers' Questions re: Meningitis Outbreak
NECC News: Ohio Clinics from Akron to Zanesville that Received NECC Drugs May-October 2012
NECC News: Fungal Meningitis Lawsuits Filed in Minnesota, Michigan, New Jersey, Tennessee, and Virginia (updated October 17)
NECC News: NECC Cuts Jobs, FDA Investigates More Products
NECC News: Two More Injections Possibly Linked to Fungal Meningitis Outbreak per FDA
House of Representatives Wants to Speak with NECC and Woman Files First Meningitis Lawsuit
NECC Loses Ohio License and 2004 Meningitis Lawsuit Comes to Light
What Epidural Steroid Patients Need to Know about the NECC Fungal Meningitis Outbreak
The Legal Examiner and our Affiliate Network strive to be the place you look to for news, context, and more, wherever your life intersects with the law.
Comments for this article are closed.