The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are currently investigating a recent outbreak of fungal meningitis among patients who received medications from New England Compounding Center (NECC) on or after May 21, 2012.
The Senate Health, Education, Labor and Pension (HELP) Committee has released a report detailing the safety record of the compounding facilities in question.
Most Current FDA Alert: November 12, 2012:
The FDA announced that Ameridose, LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in circulation. 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 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. 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.
At this time, the FDA is 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. 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.
Update from FDA: FDA is aware that the voluntary shutdown of Ameridose and the recall of Ameridose products may affect supplies of certain life-saving drugs for some health care systems. FDA has identified six Ameridose products on the FDA critical shortage list, which already were in shortage prior to the recall. The recall has the potential to exacerbate one or more of these shortages:
- Sodium Bicarbonate Injection
- Succinylcholine Injection
- Atropine Sulfate Injection
- Bupivacaine Hydrochloride Injection
- Lidocaine Hydrochloride Injection
- Furosemide Injection
For these 6 drugs in shortage, these are the actions FDA will continue to take the following actions:
- FDA is working with manufacturers for these 6 drugs, requesting that they ramp up production if they are willing and able to do so.
- For any manufacturers for these 6 drugs that may be experiencing manufacturing/quality problems, 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, 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, FDA will expedite the reviews of any pending applications that could help with addressing the shortages.
- FDA is identifying any additional manufacturers willing to initiate or increase production.
FDA encourages health care providers and facilities to use only FDA-approved drugs if possible. If you believe there is a drug entering shortage, please notify our Drug Shortage Staff at firstname.lastname@example.org
FDA releases initial inspection report (11/12/12).
New England Compounding Center (NECC):
FDA is making available two lists of customers (consignees) who received products that were shipped on or after May 21, 2012 from New England Compounding Center’s Framingham, MA facility. The first list includes customer names and addresses, organized by state. The second list contains the same basic information as the first list, but is organized alphabetically by customer name and also includes the specific products shipped, the quantities of product shipped, and the shipping date. The lists were prepared based on information provided by NECC, and FDA cannot vouch for the completeness or accuracy of the lists. Products shipped by NECC may be missing from the list and facility information may be incomplete. Nevertheless, this is the best information we have available, at this time, to help inform facilities and healthcare providers of NECC products shipped to their facilities since May 21, 2012.
Download the FDA patient notification letter template and view the lists of customers (consignees) who received the NECC products in question (below).
Read the full alert: Fungal Meningitis Outbreak: FDA Provides NECC Customer List
For more information, access the resources below: