BETHESDA, MD 19 October 2012—Federal officials on October 18 announced that the black mold Exserohilum rostratum was detected in sealed vials of methylprednisolone acetate produced in August by the New England Compounding Center (NECC).
The mold was found in vials from lot 08102012@51, which contains 80 mg of methylprednisolone acetate per milliliter of preservative-free solution and was recalled, along with two other lots of the drug, on September 26. Testing is in progress on the two other lots, according to FDA.
In the wake of the outbreak, which has sickened 271 patients in 16 states and caused 21 deaths, NECC has recalled all of its products. FDA on October 4 advised health care providers to avoid using any product made by the company.
The agency on October 15 asked health care providers to contact patients treated with any injectable medication produced by NECC after May 21 and inquire about their health.
FDA on October 18 released a patient notification letter that clinicians can customize and use for patient outreach.
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