A company with the same founders as the specialty pharmacy linked to a deadly meningitis outbreak is recalling all of 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 provide specific details about Ameridose’s recall, which was announced on Wednesday. Woodcock would only say, “We found there was not adequate assurance of sterility in their sterile products.” However, she stressed the agency knows of no infections linked to the recalled products. In a statement, Ameridose declared it issued the recall “out of an abundance of caution.”
“Ameridose and FDA agree that the use of injectable products that are not sterile can represent a series hazard to health and could lead to life-threatening injuries and/or death,” said the company. “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.”
Ameridose makes several injectable drugs which can be used in anesthesia or to correct acid imbalances in the body during critical care. Ameridose agreed to shut down for inspection in October after contaminated steroids from the New England Compounding Center (NECC) were linked to a growing meningitis outbreak.
According to the Centers for Disease Control and Prevention (CDC) there are 386 meningitis cases throughout the country. There are 28 deaths in the following states: Florida (3), Indiana (3), Maryland (1), Michigan (7), North Carolina (1), Tennessee (11) and Virginia (2)
Tennessee leads with the most cases and deaths reported.
Ameridose and NECC were founded by brothers-in-law Barry Cadden and Greg Conigliaro. According to Ameridose, it is a separate entity. However, Cadden, who was the lead pharmacist at NECC, has resigned from Ameridose.
The Boston Globe is reporting that despite internal tests showing widespread contamination, NECC sent customers a report card touting the cleanliness of its labs. A company spokesman had no comment.
Based on reporting by the Associated Press.