Massachusetts officials have begun a criminal investigation into the specialty pharmacy.
Federal investigators said last Friday that a tour of the Framingham plant found foreign, “greenish-black” material in some vials of the injectable steroid suspected as the cause of the illnesses. The contaminated product was one of a host of potential violations discovered during a recent inspection of the New England Compounding Center’s plant.
On Wednesday, the U.S. Food and Drug Administration said that a company with the same founders as the New England Compounding Center was voluntarily recalling all of its products.
“Ameridose LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in circulation,” the FDA said in a statement.
“The FDA is currently conducting an inspection of Ameridose’s facility,” the agency said. “Although this inspection is ongoing, the FDA’s preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility.”
While the FDA said there have been no reports of infections linked to Ameridose products, the agency recommended the recall “out of an abundance of caution.”
“Health care professionals and patients may dial the FDA’s Drug Information Line at 855-543-DRUG  and press [the star sign] to get the most recent information regarding the Ameridose recall and speak directly to a pharmacist,” the agency added.
The New England Compounding Center is what’s known as a compounding pharmacy. These pharmacies combine, mix or alter ingredients to create drugs to meet the specific needs of individual patients, according to the FDA. Such customized drugs are frequently required to fill special needs, such as a smaller dose, or the removal of an ingredient that might trigger an allergy in a patient.
Compounding pharmacies aren’t subject to the same FDA oversight as regular drug manufacturers are, but some members of Congress now say the meningitis outbreak highlights the need for more regulatory control.