All unexpired drug products produced by Ameridose are voluntarily being recalled by the manufacturer. Ameridose is a company that shares the same management as New England Compounding Center (NECC), the firm associated with compound drugs linked to the ongoing meningitis outbreak. The Food and Drug Administration (FDA) and the Massachusetts Board of Registration in Pharmacy are conducting an investigation of the Ameridose facility as part of the ongoing fungal meningitis outbreak. No patients using Ameridose products have reported any infections.
While the investigation is ongoing, preliminary findings have raised concerns about the lack of sterility assurance for products produced at and distributed by this facility. Use of non-sterile injectable products can be serious and can lead to health risks including life threatening conditions, according to the FDA. Ameridose ceased all pharmacy and manufacturing operations on October 10, 2012 under an agreement with the Massachusetts Board of Registration in Pharmacy.
Because no patients have reported any infections or complications from the use of Ameridose products, the FDA sees no need for health care professionals to follow up with patients that have received Ameridose products. Health care professionals, however, should stop using all Ameridose products at this time.
Critical Drug Shortages
Some Ameridose products currently appear on the critical drug shortage list. The FDA is working with alternative manufacturers to maintain supplies of these life-saving drugs. “The agency is taking all steps within its authority to help prevent or alleviate shortages and to minimize the impact this recall may have on drug supplies,” said FDA Commissioner Margaret A. Hamburg.
Ameridose is notifying its customers by fax and is arranging for the return of all of its products. Ameridose has advised customers that have products under recall to examine their inventory, identify recalled products, quarantine those products, complete a form regarding the current status of the products and fax the form to 508-656-6596 or email the form to email@example.com. Hospitals, clinics and health care professionals with question can also call 1-888-820-0622.
Any adverse reactions to an Ameridose product should be reported to the FDA’s MedWatch by fax at 800-FDA-0178 or at the MedWatch website. Health care professionals and patients may dial the FDA’s Drug Information line at 855-543-3784 and press * to get the most recent information regarding this recall.