On September 26, 2012, New England Compounding Center (NECC) recalled more than 17,000 steroids delivered to medical facilities in 23 states because of an outbreak of fungal meningitis suffered by patients injected with the contaminated product. Now this past week Med Prep Consulting, Inc. “voluntarily” recalled all lots of its products after being notified by a Connecticut hospital that it observed visible particulate contaminants confirmed to be mold in 50 ml bags of Magnesium Sulfate 2 grams in Dextrose 5% for Injection products compounded at its facility.
Administration of an intravenous product found to be contaminated with mold could result … Read the rest
This past Friday, October 26, 2012, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the New England Compounding Center (NECC) that produced contaminated steroid injections and triggered an FDA investigation of a multistate fungal meningitis outbreak among patients who received the injections. The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions at NECC’s Framingham, Massachusetts facility.
The investigators observed problems with NECC’s ability to maintain its clean room, which is the enclosed space that is designed and maintained to have a controlled environment … Read the rest
Many of our clients suffer from intractable neck pain and face difficult risk-laden choices as to how to try to obtain relief from their debilitating symptoms. For example, many are given the option of undergoing surgery, which could potentially result in paralysis, or first trying a series of epidural injections. Patients are usually told that the injections may not work, but now they have something more to fear: life-threatening fungal meningitis. The latest report is that there are 119 cases of people who were infected from contaminated steroid injections (preservative-free methylprednisolone acetate (80mg/ml)). 11 people have died and many others … Read the rest