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Hundreds of drugs recalled, ranging from antibiotics to blood thinners, pain prescriptions to pediatric medications recalled
Update: “Sharp Grossmont Hospital and any other entity of Sharp HealthCare does not purchase products from Ameridose, the pharmaceutical company that is linked to the drug recall,” spokesman Bruce Hartman has informed ECM.
October 31, 2012 (Washington D.C.)--The U.S. Food and Drug Administration announced today that Ameridose, LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products due to serious sterility concerns. The move follows 54 cases of fungal meningitis linked to steroid injections.
However, the drug recall is much broader, including hundreds of drugs in oral and inhalable forms as well as injectibles. The list includes many commonly used medications such as Ibuprofin, Acetaminophen, Lidocaine, Penicillin, Vancomycin, Oxytocin, Morphine, Vancomycin and Heparin, to name just a few.
View a complete list of all products subject to this recall here with more information at www.ameridose.com. Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logo. Despite the recall, doctors and healthcare professional have NOT been urged by the FDA to followup with patients who received these drugs, so check the list carefully to see if medications you have received may be on the list. Scroll down for more information.
“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.
Most products produced at and distributed by the Ameridose 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.
“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.
For more information:
Impact of Ameridose shutdown and recall on drug supply
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