With 17,000 vials of potentially deadly steroid medication in the market, the CDC and FDA have finally found an unopened vial that tested positive for Exserohilum rostratum, a black-brown fungus that has also been found in the cerebrospinal fluid of patients who contracted meningitis. The fungal meningitis outbreak that has sickened hundreds (and growing every day) has now been conclusively linked to the maker of the vial of steroid medication (the smoking gun), the New England Compounding Center (NECC). The company has killed 20 people so far with its contaminated medication.
Although this new evidence is good news, it means NECC is that much closer to filing for bankruptcy.
In 2005, NECC’s National Director issued a document that spells out the reasons for NECC’s claim that it “earned a national reputation as a provider of high quality compounded medications and excellent services to patients and prescribers.” Among other things, NECC claimed that:
- “Samples from final product batch lots [were] sent to an independent lab…for sterility, endotoxin (pyrogenicity), and potency testing.”
- “Tested medication is quarantined and dispensed only after sample has tested negative for endotoxin and microbial contamination. Test results are provided with each order if requested.”
- “An independent 3rd party pharmacy consultant inspects our facility periodically to ensure we are observing all USP 797 requirements.”
- “All personnel are trained/validated by an outside agency…”
- “Class 10 microenvironments are validated every 6 months by [an outside agency].”
