HealthDay News — The sister company to the pharmacy that distributed tainted steriods responsible for the ongoing fungal meningitis outbreak, which has now claimed 29 lives, is recalling all of it’s products.
Ameridose, of Westborough, Mass., manufactures sterile injectible products and oral syringes, and shares ownership with the New England Compounding Center.
As yet, there have been no reports of patients experiencing infections or other complications in association with Ameridose products. Instead, the company said, the recall is being undertaken out of of an “abundance of caution.”
The FDA said in a statement that it has “concerns about a lack of sterility assurance” for Ameridose products, based on preliminary findings from an inspection of the manufacturer’s facility that was conducted as part of the ongoing investigation of the fungal meningitis outbreak.
Ameridose stopped production on Oct. 10, 2012. The FDA is recommending health care providers stop using products manufactured by the company and return any unused medication to the facility. Hospitals, clinics, and other customers with Ameridose products can call the company at 888-820-0622 for guidance on returning the products.
At this time, the FDA is not recommending that clinicians follow up with patients who have received medications manufactured by Ameridose products, as no actual adverse events have been reported.
In the meantime, the death toll in the fungal meningitis outbreak linked to preservative-free methylprednisolone acetate made and distributed by the NECC has climbed to 29 people in 19 states.
Tennessee has reported the most deaths at 11, followed by Michigan with seven. Virginia, Florida, and Indiana have each reported three deaths, and Maryland and North Carolina have had one each.
A total of 368 cases of fungal meningitis have been identified in the outbreak, including one stroke and nine cases of peripheral joint infection.
CDC testing identified the black mold Exserohilum rostratum in unopened vials from two of the three affected lots of recalled steroids produced by NECC. Testing on the third lot is ongoing.
Steroids from the pharmacy were first recalled on Sept. 26, and on Oct. 6, NECC recalled all of it’s products. Health officials think it’s unlikely that any new infections will occur, since the form of mengingitis in the outbreak is not contagious.