Feds: NECC Knew Conditions Were Not Sterile

Mold and other bacteria was found not only by the inspectors, but by staff at NECC.

After a raid of the New England Compounding Center earlier this month, federal inspectors said members of the NECC staff knew the conditions were not sterile. According to Fox 25, in the past year, dozens of cases of mold and bacteria were documented in supposed sterile rooms. Inspectors said there is no sign the pharmacy did anything with these reports; no signs of investigation or cleanup were noted. Yesterday, the FDA issued a copy of the FDA Form 483, which found problems with New England Compounding Center. According to Fox, NECC responded to the FDA's report: "We received the Food and Drug Administration's Form 483 earlier today. We will review this report and will continue our cooperation with the FDA. We will follow the existing …

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CDC: 23 Dead, 284 Infected in Fungal Meningitis Outbreak

Since the first death, lawsuits, in 6 states, have been filed against Framingham-based New England Compounding Center.

The Centers for Disease Control and Prevention increased it numbers in the deadly meningitis outbreak to 23 dead. The new deaths reported in Tennessee and North Carolina. The CDC said the outbreak, linked to tainted steroids produced at New England Compounding Center in Framingham, has reached 16 states with 284 cases, including 23 deaths. New England Compounding Center (NECC) recalled steroids tained with a fungus, in late September. Over Columbus Day weekend, NECC recalled all 1,200 of its products. For a list of all the products, click here. Last week, federal officials raided the Waverly Road specialty pharmacy. Since the first death, lawsuits, in 6 states, have been filed against NECC. NECC has suspended operations,  and surrendered …

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Heart Transplant Patient Infected with Fungus; May Be Linked to Framingham Pharmacy

The Federal Drug Administration says a medicine produced by New England Compounding Center may be linked to a fungal infection in a heart transplant patient.

The Federal Drug Administration says a medicine produced by New England Compounding Center may be linked to a fungal infection in a heart transplant patient. New England Compounding Center, a specialty pharmacy on Route 135 in Framingham, has been linked to a deadly meningitis outbreak that has killed 15 patients and infected 199 others in 15 states. The company produced a steroid, injected in the back, to relieve pain, that may have been contaiminated with Exserohilum, a fungus that causes meningitis. The type is not contagious. In a press release, the FDA said it believes other drugs produced by the Framingham pharamacy may be causing infections in individuals. It suggested heart and eye patients could be at risk. PRESS RELEASE: As a …

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Four More Contract Meningitis in National Outbreak

Four in New Hampshire have now contracted the fungal meningitis linked to steroids from a Framingham pharmacy.

Add four patients to the total of people who have contracted fungal meningitis linked to steroids distributed from the New England Compounding Center in Framingham, according to the Boston Herald. Earlier in October, the New England Compounding Pharmacy, Inc. announced a recall of all products currently in circulation that were compounded at and distributed from its facility in Framingham. The four, who are from New Hampshire, are between the ages of 40 and 60, and being monitored and receiving medical care. According to the Center for Disease Control and Prevention, 15 people died and 197 have gotten sick in 13 states from the steroids.

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Gov: NECC May Have Misled Regulators

The Framingham-based New England Compounding Center produced a steroid linked to a deadly meningitis outbreak, which has killed 12 people and infected 130 others across 10 states.

New England Compunding Center, which has been tied to the national memingitis outbreak, may have misled regulators and completed work beyond its state license, said Massachusetts Gov. Deval Patrick. The Framingham-based specialty pharmacy produced a steroid, that health officials believe killed 12 people, infected 130 others across 10 states, with a fungal meningitis. The governor told reporters Wednesday, "What they were supposed to be doing is filling specific prescriptions for specific patients, as I think any of us would understand a pharmacy to do. What they were doing instead is making big batches and selling them out of state as a manufacturer would and that is certainly outside of their state license." While the compounding …

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12th Person Dies From Meningitis

The Framingham-based company's Recall Operations Center will process and manage the removal of all 1,200 NECC products from circulation; 12th person has died from the tainted steroids.

UPDATED: A 12th person has died, first in Florida, from the tainted steroids, produced by the Framingham company. *** Framingham-based New England Compounding Pharmacy, Inc. dba New England Compounding Center (NECC), Wednesday announced it has established a Recall Operations Center to process and manage the removal of all 1,200 NECC products from circulation, according to a press release. As a precautionary measure, due to the potential risk of contamination, NECC on Oct. 6 initiated a recall of all products currently in circulation that were compounded at and distributed from its facility in Framingham, Massachusetts. This action was taken in cooperation with an investigation being conducted by the U.S. Food and Drug Administration, the …

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Letter to the Editor

LETTER: FDA Failed in its Oversight of Specialty Pharmacy in Meningitis Outbreak

Dr. Michael Carome: "What is particularly tragic for the families of those who have been sickened or killed by the tainted drug is that this situation was completely avoidable."

The now widely publicized outbreak of life-threatening fungal meningitis in back-pain patients linked to steroid injections prepared by a compounding pharmacy highlights the failure of the Food and Drug Administration’s (FDA’s) regulatory oversight of drugs prepared and sold by such pharmacies. What is particularly tragic for the families of those who have been sickened or killed by the tainted drug is that this situation was completely avoidable. The steroid injections, distributed by the New England Compounding Center in Framingham, have been linked to at least 119 infections in 10 states, and as many as 13,000 people have been exposed. The contaminated injections have been recalled, along with all other products distributed by the New …

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