FDA Update

October 19, 2012

Facts you should be aware of regarding a list of Alabama hospitals and facilities released Oct. 18, 2012, by the FDA about the infective products from NECC (New England Compounding Center):
·        SMC ordered from NECC one shipment of Cardioplegia solution because of a drug shortage at that time.
·        NECC shipped 10 doses of Cardioplegia solution to SMC on 7/9/12.
·        Dr. Donald Williamson, State Health Officer of the Alabama Department of Public Health, said that none of the NECC products shipped to Alabama has been shown to be contaminated.
·        7  patients possibly received some of the 10 doses from NECC of Cardioplegia during open heart procedures at SMC in July 2012.
·        If the product was used at SMC, the period of use was 7/13/12 until 7/26/12.  
·        These patients have been notified as a precautionary measure recommended by CDC and FDA.
·        SMC is maintaining constant communication with ADPH to monitor further developments.
·        Patient inquiries to SMC should call Infection Control Director Beth Beck at 251.460.5329 or 251.752.4930.
·        We want to reassure our community and our patients that we consider their welfare and safety our highest priority.