DIVISION OF DRUGS, DEVICES AND COSMETICS
Information on the Meningitis Occurrences
A voluntary recall of all New England Compounding Center (NECC) products distributed since January 2012 has been issued by the company, in coordination with the Food and Drug Administration (FDA). These products should be removed from use immediately, and facilities should follow appropriate FDA recall procedures.
Based on guidance from the FDA, the Department of Health is advising health care professionals to follow up with patients who received any NECC medication after May 21, 2012, and to alert these patients to the potential risk of infection at the site of injection or adjacent tissue space.
This recall is in addition to the October 5th recall of the three contaminated lots of NECC methylprednisolone acetate used for epidural back injections. The numbered contaminated lots are 05212012@68, 06292012@26 and 08102012@51. These lots have been associated with a non-contagious fungal meningitis outbreak.
If symptomatic, patients should be evaluated immediately by their health care professional and monitored or treated as necessary. Patients without symptoms should be evaluated by their health care professionals as soon as possible. At this time, there has not been a case of septic arthritis related to contaminated steroid joint injections.
The list of all products subject to this recall can be accessed here.
A list of facilities who may have received any product from the NECC is available here.
Additionally, Ameridose, LLC, has voluntarily recalled all of its unexpired products in circulation. A complete list of all products subject to this recall can be accessed at www.ameridose.com.
The FDA is advising health care professionals to stop using all Ameridose products and follow the recall procedures provided by 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.
For Consumer information, please visit the Department of Health's website or call the toll-free hotline at 866-523-7339.
DBPR Q&A for Facilities
Q: I have product in my facility from the New England Compounding Center. What do I do with it?
A: Step One: Identify all product received from the New England Compounding Center.
Step Two: Physically remove the product into a separated area in your facility. Maintain proper storage conditions for each product according to the product label.
Step Three: Verify your inventory using patient records and invoices to ensure that all product received from the New England Compounding Center has been accounted for and separated.
Step Four: Follow all applicable FDA product recall procedures.
Q: If I choose to do so, how do I dispose of the product?
A: Follow FDA product recall procedures.