Ameridose LLC, a company that ceased operations on October 10 under an agreement with the Massachusetts Board of Registration in Pharmacy, has now voluntarily recalled all of its unexpired drug products to the health professional level, FDA said today.
During an ongoing FDA inspection of Ameridose facilities in Westborough, MA, the agency became concerned about a lack of sterility assurance. “Ameridose is a company sharing common management by the same parties as New England Compounding Center of Framingham, MA, the firm associated with compounded drugs linked to the ongoing fungal meningitis outbreak,” FDA said in a news release. “Because the preliminary results of the FDA’s inspection raise concerns about the sterility assurance of Ameridose’s products, the FDA is advising health care professionals to stop using all Ameridose products and follow the recall procedures provided by the firm.”
No reports of patients being infected or other known problems have been received. Health professionals should quarantine Ameridose products and contact the company at 888-820-0622 for instructions on their return. FDA said that health professionals do not need to contact patients who have received Ameridose products.
“The volume on this [recall] is very large,” an FDA official said during a stakeholder briefing. “The company is undertaking this recall and reaching out to all people who purchased their products. … We will not be providing state-by-state lists of where products went or what that product was.” A complete list of recalled products is being posted on the Ameridose website; they include injectable sodium bicarbonate, succinylcholine, atropine, bupivacaine, lidocaine, and furosemide.
Ameridose has been operating as a compounding pharmacy and repackager. The October 10 agreement with Massachusetts expires on November 6. Officials on the call would not speculate on whether the company might be allowed to resume production at that time.
FDA noted that some of the recalled products contain drugs that are on the agency’s critical shortage list. The agency said it is “working with alternative manufacturers to maintain supplies of these life-saving drugs.”
Health care professionals and patients may dial the FDA’s Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the Ameridose recall and speak directly to a pharmacist, the agency said.