Health

Alert

 

CONTAMINATION OF ADDITIONAL MEDICAL PRODUCTS FROM NEW ENGLAND COMPOUNDING CENTER (NECC)

The Delaware Division of Public Health is issuing this health alert to provide healthcare providers and facilities with details regarding

additional contaminated medical products identified in the ongoing Food and Drug Administration (FDA) investigation associated with the

fungal meningitis outbreak. It is unknown whether facilities in Delaware received the lots of contaminated betamethasone or cardioplesia

solution.

Background

The Centers for Disease Control and Prevention (CDC) and FDA are reporting that product testing has identified bacterial contamination

with several Bacillus species and closely related bacterial organisms in unopened vials of betamethasone and cardioplegia

solution that were distributed and later recalled by NECC on October 6, 2012. These bacteria are commonly found in the environment and

have been rarely reported as a cause of human disease; it is not known how product contamination with these species might affect

patients. CDC has not received reports of laboratory-confirmed cases of infection due to Bacillus or closely related organisms

linked to these products.

The following table provides CDC and FDA laboratory testing results for contamination and product lot numbers. Other cultures for these

products, including fungal cultures, are pending.

 

Medication	Lot number	Microbial contamination
Betamethasone	08202012@141	Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp.
Betamethasone	07032012@22	Bacillus niabensis, Bacillus circulans
Betamethasone	07302012@52	Bacillus lentus, Bacillus circulans
Cardioplegia solution	09242012@55	Bacillus halmapalus, Brevibacillus choshinensis

 

Recommendations

1. Clinicians should consider these product findings when reviewing laboratory results from patients who have been exposed to a NECC

   product.

2. Do not use any product produced by NECC as previously recommended by CDC and FDA.
3. Continue follow-up of patients who received any injectable NECC product, including betamethasone or cardioplegia solution purchased

   from or distributed by NECC after May 21, 2012.

4. For healthcare providers diagnosing and treating symptomatic patients who have received NECC products, CDC recommendations have not

   changed and can be found at http://www.cdc.gov/hai/outbreaks/clinicians/index.html#Guidance.

Additional Information

• CDC health alert: http://www.bt.cdc.gov/HAN/han00333.asp.  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm326370.htm
• Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products

  online at www.fda.gov/MedWatch/report.htm

• Delaware Division of Public Health, Bureau of Epidemiology (24/7): 1-888-295-5156.

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