Mass. Firm Tied to Closed Pharmacy Issues Recall
BOSTON - A company with the same founders as the specialty pharmacy linked to deadly meningitis outbreak said Wednesday that it’s recalling all its products after federal inspectors said it must improve its sterility testing process.
Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, said she could not be specific about the problem at Ameridose. She would only say: "We found there was not adequate assurance of sterility in their sterile products."
Woodcock stressed the agency knows of no infections linked to the recalled products. In a statement, Westborough-based Ameridose said it issued the recall "out of an abundance of caution."
"Ameridose and FDA agree that the use of injectible products that are not sterile can represent a serious hazard to health and could lead to life-threatening injuries and/or death," the company said. "We are undertaking this recall to assure customers that when Ameridose products are shipped, they are fully in conformance with all of the FDA’s recommendations."
The company posted a lengthy list of the recalled products, including painkillers, anesthetics and blood thinners, on its website Wednesday.
Woodcock said the large recall could exacerbate some shortages for critically needed drugs and the agency is working to head off any supply problems.
An FDA spokeswoman said among the steps the agency can take is to ask manufacturers to increase production or help them solve quality problems that are stopping production. It can also look for viable overseas producers if no domestic manufacturers are available.
Ameridose makes an array of injectable drugs, which can be used in anesthesia or to correct acid imbalances in the body during critical care, among other ways.
Ameridose agreed to shut down for inspection in October after tainted steroids from the New England Compounding Center were linked to a fungal meningitis outbreak that’s spread to 19 states, sickening 377, 29 of whom have died.
Ameridose and NECC were founded by brothers-in-law Barry Cadden and Greg Conigliaro. Ameridose says it is a separate entity with distinct management. Since the outbreak, Cadden, the lead pharmacist at NECC, has resigned from Ameridose.
In a related story, The Boston Globe reported Wednesday that NECC sent customers a report card touting the cleanliness of its labs, even though internal tests showed widespread contamination.
The Quality Assurance Report Card claimed that during the first half of 2012, there were no instances of contamination exceeding accepted standards on surfaces in "clean rooms," where the company produced sterile injectable medications.
But company records indicate that during that same period, the company’s own internal testing showed that 33 surface samples from the clean rooms contained bacteria or mold at levels requiring corrective action. Those results were disclosed in a report released Friday by FDA investigators.
A company spokesman had no comment.
Three consultants who were shown the report card by the Globe described it as promotional material rather than a scientific report. For instance, they said, it lacked basic scientific data, such as how many tests were conducted to detect bacterial and mold contamination.
"Their marketing material is baloney. They are just saying what they want to say," said Stephen Runge, president of nanoCLEAN Decontamination Services, a Quincy company.
Two of the three lots of contaminated steroids were produced during the time covered in the company’s report card.