Compounding Pharmacy Ameridose Recalls Products Under FDA
The death toll and illnesses caused by fungal meningitis linked to a compounding pharmacy continue to rise.
The New England Compounding Center (NECC), a Westborough, Massachusetts-based company, is considered responsible for infecting more than 409 people with fungal meningitis and killing 30 people. Everyone received contaminated steroid injections for pain made by NECC.
Besides the 409 cases of fungal meningitis or stroke linked to fungal meningitis, there have been another 10 peripheral joint infections which have not led to death, according to the Centers for Disease Control and Prevention (CDC).
Florida has seen three deaths and 23 cases of fungal meningitis; Michigan has 119 cases and 7 deaths; Tennessee 78 cases and 13 deaths; Indiana 51 cases and 3 deaths; New Jersey 24 cases and no deaths; Maryland 23 cases and one death.
In all, 19 states have been affected.
The FDA admits Ameridose makes some drugs that are already in short supply in the U.S. such as sodium bicarbonate used for advanced cardiac life support and succinylcholine, a paralyzing agent used during surgery. The agency warns hospitals they could face shortages of both of those drugs, reports Reuters.
The recall is not based on reports of patient infections, reminds the FDA in a press announcement.
The unexpired products in circulation can be identified by a company logo on the package.
“The FDA is working with alternative manufacturers to maintain supplies of these life-saving drugs,” says the news release.
An FDA inspection report on NECC found some vials with a greenish black foreign matter, and some with a white filamentous material. Interestingly, NECC is located next to a mattress recycling plant. FDA inspectors found the company had machines that were dirty and soiled floor mats.
The FDA reported on November 2 that samples from two additional recalled NECC products include bacteria present in three separate lots of injectables including Betamethasone and Cardioplegia solution.
Previously, the fungus Exserohilum rostratum was identified in NECC-supplied, preservative-free methylprednisolone acetate (MPA).
Both NECC and Ameridose were selling outside of their localized markets, as is typical for a compounding pharmacy, and Pharmalot reports manufacturing and selling sterile product in bulk was not allowed under the company’s state licenses.
NECC has already hired a defense firm in preparation for civil litigation, the same firm that defended pharmaceutical makers in the diet drug fen-phen litigation.