FDA Safety Recall

Oct/19/2012

As federal regulators continue to investigate the outbreak of fungal meningitis linked to contaminated steroid methylprednisolone injections, we’d like to reassure our patients that they are NOT at risk from steroid injections used at Sarasota Memorial Hospital and our Pain Care Centers. The contaminated vials were manufactured and distributed by the New England Compounding Center (NECC). We did not purchase any methylprednisolone injections from NECC or other compounding pharmacy. The product used at Sarasota Memorial is Depo-Medrol®, which is not part of the investigation or FDA recall. It is manufactured by Pharmacia & Upjohn, a division of Pfizer.

This week, investigators expanded the list of NECC products of concern to include some drugs used in heart and eye surgery. We do not purchase those medications from the NECC either.

Sarasota Memorial Hospital was included on a list of facilities that have purchased other products from the NECC, which has recalled all of its products out of an abundance of caution.

We’d like to reassure patients that our contact with the NECC has been extremely minimal. We have purchased only one product that may eventually fall under federal review but has not been associated with the outbreak – 17-hydroxyprogesterone – an injection given in the muscle to prevent pre-term labor in women with at-risk pregnancies. The injections have been given to eight patients since May (the period under review). Physicians for all eight patients have been notified and are communicating with their patients. Patients on this medication have been monitored weekly in regular pregnancy check-ups and no adverse effects have been noted. The recalled NECC product has been sequestered and will be returned or discarded as directed by authorities. We will continue to treat patients when needed with 17-hydroxyprogesterone, but will purchase the product from a local compounding pharmacy.

We also have purchased Phenol and Acetic Acid – two topical antiseptics – but believe there is no risk associated with those products.

Sarasota Memorial's drug recall information line is (941) 917-1953. If you have questions or concerns, please leave a message with your phone number.

For more information about the meningitis outbreak and list of recalled products/facilities, visit the FDA website at: http://www.fda.gov/drugs/drugsafety/fungalmeningitis/default.htm

Media Contact: Kim Savage
Kim-savage@smh.com
(941) 917-6271 

Reporting Concerns | PRIVACY POLICY | Terms of Service | Online Bill Pay | Mobile Site | Smartphone App
Site optimized for Chrome or Firefox | Copyright © 2014. Sarasota Memorial Health Care System. All rights reserved.