Meningitis Outbreak: FDA Reveals Inspection Findings, Updates List of Affected Customers
October 31, 2012 | Risk Management News
During an inspection of the New England Compounding Center (NECC) in Framingham, Massachusetts, the U.S. Food and Drug Administration (FDA) found visible greenish-black material in 83 medication vials and white fibers floating in 17 more, states an October 26, 2012, Boston Globe article. According to the article, FDA also found green discoloration in the pharmacy’s autoclaves and various other violations of sterility standards. As a result of the nationwide fungal meningitis outbreak linked to the facility (see the October 24, 2012, HRC Alerts), NECC announced a recall of all its products on October 6, 2012; a complete list of the affected products can be accessed at FDA’s website. Additionally, FDA has posted revised lists of healthcare providers, by state, who received products shipped from NECC on or after May 21, 2012. The agency continues to recommend that healthcare providers follow up with patients who received any injectable product or cardioplegic solution purchased from or produced by NECC after May 21, 2012, and provides a patient notification letter template that providers may modify and use in these situations.