Ameridose LLC, sister company to the New England Compounding Center (NECC), the company believed to be the culprit in the ongoing and growing fungal meningitis outbreak that has sickened 377 and killed 28 people in 20 states, is recalling its products.
Nine cases of peripheral joint infections, a result of tainted steroids injected into a knee, hip, shoulder, or elbow have also been reported, according to the U.S. Centers for Disease Control and Prevention (CDC), which noted that no deaths have been linked to peripheral joint infections.
Ameridose agreed to recall its products after the U.S. Food & Drug Administration (FDA) discovered some issues with its testing procedures, the Boston Globe wrote. “During the course of its on-going inspection of our facility,” Ameridose said, the FDA “has notified Ameridose that it will be seeking improvements in Ameridose’s sterility testing process.” Ameridose provides thousands of hospitals and health providers nationwide, noted the Globe; the drug maker said it has not received any illness reports related to its products.
Dr. Janet Woodcock, FDA director of its Center for Drug Evaluation and Research, said that during Ameridose’s production facility inspections, investigators did not find “an adequate assurance of sterility in the manufacturing of their sterile products.’’ Woodcock told the Globe that the agency believes the recall will be large. Because of this, the federal regulator said, there will be a worsening of the current shortage of sterile injectable drugs; the FDA is collaborating with other drug makers to assist in increasing production of drugs that might be challenging for hospitals and doctors to procure during the recall, said Boston.com. Ameridose and the NECC share owners.
The NECC was subject to a third-party inspection in 2006. That inspection revealed that the firm was lacking in safety protocols that could endanger the sterility of the drugs it was commissioned to produce. The inspection noted that the NECC failed to have any standard written procedures for manufacturing drugs, including the operation of equipment, and that sparse record keeping was done by the company, overall. When Massachusetts health officials visited NECC labs earlier this year, an inspection report obtained by the Associated Press (AP) found that the company had allegedly improved on these deficiencies. Still, NECC was able to ship more than 14,000 potentially contaminated vials of an epidural steroid injection. The FDA investigation determined that 50 sample vials of methylprednisolone acetate were contaminated with a fungus responsible for the deadly meningitis outbreak.
NECC was reportedly only licensed to produce enough vials of methylprednisolone acetate that were confirmed by prescriptions already written. Considering the volume of vials recalled by the company after they were linked to the outbreak of fungal meningitis, it has become clear that NECC likely violated its license in producing so many vials of the drug without a prescription to confirm them.
Regulators at the state and federal level have also said that inspectors discovered an array of sources of potential contamination in and around NECC’s clean rooms and that injections were shipped to customers before NECC completed its sterility tests, said the Globe. Meanwhile, regulators discovered similar problems at Ameridose in the past. For instance, a 2008 FDA inspection revealed several problems. Ameridose did not sufficiently test all the lots of its drugs, shipping some prior to receipt of sterility test results. Soon after, Ameridose recalled a painkiller because it was too potent, said the Globe. Some former Ameridose employees told the Globe that they were worried about the firm’s safety procedures.
Earlier this year, Novation LLC, a group purchasing company, told customers that it intended to divest itself of its relationship with Ameridose at the end of October over concerns it had regarding controls there. After Ameridose sued Novation, the two firms agreed to extend their relationship, said the Globe.
Ameridose said it was notifying customers by fax and was arranging for return of the recalled products.