As Fungal Meningitis Outbreak Grows, Another Compounding Pharmacy Announces Drug Recall
Another compounding pharmacy is recalling all of its products in the wake of a fungal meningitis outbreak that has sickened well over 300 people in 19 states, killing 28. According to a report from The Wall Street Journal, Ameridose LLC decided to announce the drug recall after federal regulators asked that it beef up its sterility testing.
The multistate outbreak of fungal meningitis and other fungal infections has been linked to tainted epidural steroid injections supplied by the New England Compounding Center (NECC) of Framingham, Massachusetts. According to the U.S. Centers for Disease Control (CDC), 368 cases of meningitis have been reported in people who received NECC steroid shots to treat back pain, while nine peripheral joint infections have been reported in patients who received the injections in knees, hips and other joints. NECC has since issued an epidural steroid injection recall, and later pulled all of its products from the market. In addition, the company voluntarily surrendered its license to operate.
Compounding pharmacies like NECC are only lightly regulated by the U.S. Food & Drug Administration (FDA), with most oversight left up to the states. However, the meningitis outbreak, along with questionable conditions – including mold contamination – uncovered by the FDA during inspections of the NECC facility early this month, are calling that lax oversight into question.
According to The Wall Street Journal, Ameridose is a sister compounding pharmacy of NECC. Janet Woodcock, head of the FDA’s drug division, said its drug recall was precautionary because manufacturing conditions at Ameridose “cannot assure sterility.” Federal and state regulators have suspended operations at Ameridose until Monday.
The Ameridose recall will cover all products made since April that haven’t passed their expiration date. While the exact number of drugs involved in the recall is not known at this time, the Ameridose website says the company “offers over 2,200 sterile admixed IV solutions and prefilled oral syringes.” According to Ameridose, none of its products have been linked to any adverse events, and no impurities have been found in any of its drugs.
According to The New York Times, Ameridose is a major supplier of injectable medications to hospitals across the country. While it is its own legally distinct entity, Ameridose is owned by some of the same people who own NECC.
Because no adverse events have been linked with the recalled Ameridose products, doctors and healthcare facilities are not being asked to contact patients treated with the drugs, as was the case with the NECC epidural steroid recall. Instead, providers are being asked to send all affected Ameridose medications back to the company. According to the Times, Ameridose said it will post a list of products affected by the recall on its site shortly.