The FDA announced 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 disclaimer icon.
See a complete list of all products subject to this recall.
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.
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 (reported to you originally in the Oct. 15 Scalpel Weekly News). 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 six 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.
- Sodium Bicarbonate Injection
- Succinylcholine Injection
- Atropine Sulfate Injection
- Bupivacaine Hydrochloride Injection
- Lidocaine Hydrochloride Injection
- Furosemide Injection
The FDA is working with manufacturers for these six drugs, requesting that they ramp up production if they are willing and able to do so. For any manufacturers for these six drugs that may be experiencing manufacturing/quality problems, the FDA is offering assistance, where appropriate, to help address these problems to enable those manufacturers to manufacture shortage drug products that are safe and high quality. If the manufacturers of critical drugs intended for the U.S. are not able to meet U.S. patient needs, the FDA explores companies that are willing and able to import foreign drugs to address the shortage in the U.S. In these instances, FDA evaluates the foreign drug to ensure that it is of adequate quality and that the drug does not pose undue risks for U.S. patients. As with shortages of any critical products, the FDA will expedite the reviews of any pending applications that could help with addressing the shortages. The FDA is identifying any additional manufacturers willing to initiate or increase production.
“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,” said FDA Commissioner Margaret A. Hamburg, M.D.
See the FDA Announcement
See the FDA Drug Shortage Announcement