Drug firm tied to meningitis cases recalls drugs amid purity questions
Ameridose, a major supplier of sterile injectable medications to hospitals across the country, emphasized that there had been no reports of impurities in any of its products.
A drug producer linked to the pharmacy at the center of a national meningitis outbreak announced a recall of all of its products Wednesday after federal regulators found it had not provided enough assurance that all the medicines it made were sterile.
The company, Ameridose, which is based in Massachusetts and is a major supplier of sterile injectable medications to hospitals across the country, emphasized that there had been no reports of impurities in any of its products and said that it had announced the recall "out of an abundance of caution."
The company sells more than 2,200 blended-drug products, including tranquilizers, anesthetics and antibiotics, according to its website. The drugs are pumped into injectable and oral syringes, and intravenous medicine bags. It said it would post the precise list of all the products on its website, ameridose.com.
The announcement represented another blow to the family behind Ameridose and its sister company, the New England Compounding Center, whose fungal-tainted steroid medication was responsible for the deaths of at least 29 people. Ameridose has taken pains to emphasize that it is legally distinct from New England Compounding. But the companies are owned by some of the same people.
Federal officials have said that Ameridose is part of the investigation because of concerns that it had some of the same business practices as New England Compounding.
Federal and state regulators have suspended operations at Ameridose until Monday. The Massachusetts Department of Public Health said Wednesday that the agreement with the company was "under review."
Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the Food and Drug Administration, said that the company offered to recall all of its products after federal officials shared the results of their inspection, which found fault with some of its sterility "assurances."
The agency is not asking health-care providers to track down patients who were given Ameridose products, she said, because there have been no reports of problems. Instead, providers are being asked to send the products back to the company.