The Massachusetts pharmacy that produced a steroid linked to a deadly outbreak of meningitis has issued a voluntary recall of all of its products. The recall by the New England Compounding Center (NECC) includes thousands of medications distributed around the country, including some widely used painkillers such as morphine, fentanyl, lidocaine and hydromorphone.
“Clinics, hospitals and healthcare providers that have product which has been recalled should stop using the product immediately,” the company said in a short statement on its website. “While there is no indication at this time of any contamination in other NECC products, this recall is being taken as a precautionary measure.”
The NECC said it would notify customers of the recall by fax. Products distributed by NECC can be identified by markings that identify New England Compounding Center by name, its acronym (NECC) or the company logo.
The Food and Drug Administration had already advised health care providers to stop using NECC products.
10/8 Update: Meanwhile, federal health officials raised the number of confirmed cases of fungal meningitis to 105 people in nine states. Eight people have died.
As many as 13,000 people have have received injections of methylprednisolone acetate, a steroid produced by NECC that is used in epidural procedures to relieve back pain. The company sold the steroid to 75 pain clinics in 23 states. It is not yet known how many people may have been affected, though it could involve thousands of patients who received spinal injections.
During an inspection of NECC’s facility in Framingham, investigators found fungus in an unopened vial. Tests are underway to determine the exact type of fungus and if it is related to the meningitis outbreak.
Meningitis is an inflammation of the protective membranes that cover the brain and spinal cord. Symptoms include headache, fever, nausea, and stiffness of the neck. People with fungal meningitis may also experience confusion, dizziness, and discomfort from bright lights. Several patients in the current outbreak have suffered strokes.
Compounding pharmacies such as NECC produce custom medications used by millions of Americans. There over 7,500 compounding pharmacies in the U.S. Many are small “mom and pop” operations, but larger ones – such as NECC — sell products to hospitals, clinics and physicians around the country. Compounding pharmacies are regulated by state agencies, with little oversight by the FDA and other federal agencies.