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Ameridose, a sister company to the New England Compounding Center (NECC) – the pharmacy at the center of investigation involving contaminated steroid products – has announced a voluntary recall of all of their products as their facilities are coming under review by the FDA.
The FDA reassures that - This recall is not based on reports of patients with infections associated with any of Ameridose’s products, and the agency recommended this recall out of an abundance of caution.
The company posted a carefully worded announcement on their website earlier today:
FOR IMMEDIATE RELEASE - October 31, 2012 - Ameridose today announced it will commence a voluntary recall of any unexpired products remaining in circulation. This action is voluntary, and represents an expansion of our cooperation with the U.S.Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy.
During the course of its on-going inspection of our facility, FDA has notified Ameridose that it will be seeking improvements in Ameridose’s sterility testing process. Ameridose and FDA agree that the use of injectible products that are not sterile can represent a serious hazard to health and could lead to life-threatening injuries and/or death.
The first sentence in the second paragraph of their press release, which reads . . .
During the course of its on-going inspection of our facility, FDA has notified Ameridose that it will be seeking improvements in Ameridose’s sterility testing process.
. . . is apparently their interpretation of the FDA’s assessment from below, which states:
FDA’s preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility.
Without comment, I'll also mention that both parties managed to agree that injecting non-sterile products is generally a bad idea, and represents a - `serious hazard to health and could lead to life-threatening injuries and/or death’.
Moving on. Here is the FDA’s statement in its entirety.
FDA NEWS RELEASE
For Immediate Release: Oct. 31, 2012
Media Inquiries: Sarah Clark-Lynn, 301-796-9110, email@example.com
Consumer Inquiries: 888-INFO-FDA
The U.S. Food and Drug Administration announced today that Ameridose, LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in circulation. Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logo . A complete list of all products subject to this recall can be accessed at www.ameridose.com .
The FDA is currently conducting an inspection of Ameridose’s facility. Although this inspection is ongoing, the FDA’s preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility. Use of non-sterile injectable products can represent a serious hazard to health that could lead to life-threatening injuries. Most products produced at and distributed by this facility are represented by Ameridose to be sterile products. Ameridose entered into a voluntary agreement with the Massachusetts Board of Registration in Pharmacy to cease all pharmacy and manufacturing operations starting on Oct. 10, 2012.
This recall is not based on reports of patients with infections associated with any of Ameridose’s products, and the agency recommended this recall out of an abundance of caution. Therefore, at this time, the FDA is also recommending that health care professionals do not need to follow up with patients who received Ameridose products. Health care professionals should stop using Ameridose products at this time, and return them to the firm.
Hospitals, clinics, health care professionals, and other customers with Ameridose products on hand should contact Ameridose at 888-820-0622 to obtain instructions on how to return products to Ameridose.
“The FDA’s top priority is to ensure that drugs are safe for the American public,” said FDA Commissioner Margaret A. Hamburg, M.D.
Together with the State of Massachusetts, the FDA commenced the current inspection of the Ameridose facility as part of the agency’s ongoing fungal meningitis outbreak investigation. Ameridose is a company sharing common management by the same parties as New England Compounding Center (NECC) of Framingham, Mass., the firm associated with compounded drugs linked to the ongoing fungal meningitis outbreak.
“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,” explained Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research.
The FDA has identified some Ameridose products that currently appear on the critical shortage list. These products were in shortage before the Ameridose recall, but supplies may be further affected as a result of the Ameridose recall. 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 shortage situations and to minimize the impact this recall may have on drug supplies,” added Commissioner Hamburg.
As new information becomes available, the FDA will issue additional public communications.
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 FDA asks health care professionals and consumers to report any adverse reactions to the FDA’s MedWatch Program by fax at 800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.