Affiliate of firm implicated in fungal meningitis remains shuttered as cases continue to rise
As the number of fungal meningitis cases continues to rise, Ameridose LLC has agreed to extend the shuttering of its facility to November 19 while Massachusetts state and federal agencies continue to examine sanitation issues at the facility. Ameridose is under the same ownership as the New England Compounding Center (NECC), which is implicated in the deadly fungal meningitis outbreak due to contaminated steroid vials.
On November 1, Ameridose, located in Westborough, Massachusetts, issued a voluntary recall of all its products following a US Food and Drug Administration (FDA) directive to improve its sterility testing process. Late last month, the Waltham location of Rhode Island-based Infusion Resource was shut down by Massachusetts health officials after inspectors found significant issues with the environment in which the drugs were being mixed. Meanwhile, according to the Centers for Disease Control and Prevention (CDC), the number of cases has risen to 404, including nine joint infections and 29 deaths. To date 19, states have been affected: Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas and Virginia.
Ameridose ceased operations on October 10; however, to date, the company has not received any reports of adverse reactions to the drugs it is recalling. Although the closures are essential for public safety, it has strained the supply of essential medications. The FDA has noted that it is in contact with other manufacturers regarding the shortage and requested that they step up production. FDA Commissioner Dr. Margaret Hamburg noted that the agency has identified a number of Ameridose products, including drugs used during surgery and to treat conditions that include congestive heart failure, that were on the current drug shortages list even before the recall. She explained, “We also know that the supply of other drugs may be affected by the Ameridose recall. FDA is doing everything we can to minimize the impact this recall may have on current drug shortages, and to prevent other shortages from occurring.”
Janet Woodcock, head of the FDA’s drugs division, said the move was precautionary because manufacturing conditions at Ameridose “cannot assure sterility.” Among the Ameridose injectables being withdrawn are those containing the muscle relaxer succinylcholine and sodium bicarbonate, which are used in critical care and anesthesia procedures. Both are in short supply. It is unclear how many products are being pulled. She noted that the action covers all Ameridose products made since April that have not passed their expiration date. Although Ameridose has not supplied a number, the company plans to list all of its products subject to the recall on its website; furthermore, the products can be identified by the Ameridose name or logo. The website notes that it “offers over 2,200 sterile admixed IV solutions and prefilled oral syringes.”
Ameridose stresses that none of its products have been subject to “adverse event” reports filed with it or the FDA; furthermore neither Ameridose nor the FDA have detected any impurities in its products. In a statement, Ameridose said, “Nevertheless, out of an abundance of caution, 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.”
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