The California Department of Public Health (CDPH) issues this All Facilities Letter to share urgent information as a result of the ongoing investigation of contamination at the New England Compounding Center's (NECC) Framingham, Massachusetts facility. On October 15, 2012, AFL 12-41.1 was released regarding a multistate fungal (and bacterial) meningitis outbreak associated with recalled lots of compounded methylprednisolone acetate. At this point, the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by NECC are of significant concern, and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection.
FDA recommends that follow-up with patients be done when the following three conditions are met:
- The medication was an injectable product purchased from or produced by NECC, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution,
- The medication was shipped by NECC on or after May 21, 2012, and
- The medication was administered to patients on or after May 21, 2012.
It is recommended that healthcare providers contact patients who meet the above criteria, and instruct them to contact you or another healthcare provider immediately if they experience any symptoms. Visit the CDC or FDA MedWatch website for the most up to date information on this matter; this is an ongoing investigation and the information is subject to change daily. The most up to date information on this outbreak may be found at the CDC or FDA MedWatch website:
(http://www.cdc.gov/HAI/outbreaks/meningitis.html).
and
(https://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/default.htm)
If you have any questions, please contact CDPH's Healthcare-Associated Infections Program at (510) 412-6060, or by email at: cdphhaiprogram@cdph.ca.gov.
Thank you for your prompt action on this matter.
Sincerely,
Original Signed by Pam Dickfoss for Debby Rogers
Debby Rogers, RN, MS, FAEN
Deputy Director
Center for Health Care Quality