The Delaware Division of Public Health (DPH) 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. In a previous DHAN, DPH reported information from the Centers for Disease Control (CDC) and FDA regarding contaminated betamethasone and cardioplegia solution. A recently released CDC Health Alert provides additional information on contaminated triamcinolone. It is unknown whether facilities in Delaware received the lots of contaminated betamethasone, triamcinolone or cardioplegia solution.
The CDC is reporting that product testing has identified bacterial contamination with several bacterial and fungal organisms in unopened vials of betamethasone, triamcinolone, and cardioplegia solution that were distributed and later recalled by NECC on October 6, 2012. To date, although CDC has received reports of illness in patients who have received the medications listed in the table below, including some patients who had evidence of meningeal inflammation, CDC and public health officials have no reports of laboratory-confirmed bacterial or fungal meningitis, spinal, or paraspinal infections caused by these products. The available epidemiological and laboratory data do not, at this time, support evidence of an outbreak of infections linked to usage of non-methylprednisolone NECC products.
The following table provides CDC and FDA laboratory testing results and product lot numbers for the contaminated triamcinolone. See the CDC health alert (http://emergency.cdc.gov/HAN/han00337.asp) for updated information on the betamethasone and cardioplegia solution.
|Medication||Lot number||Microbial contamination|
40mg/mL injectable – 1 mL per vial
|06062012@6||Bacillus lentus, Bacillus circulans|
40 mg/mL injectable – 2 mL per vial
|08172012@60||Aspergillus tubingensis, Penicillium sp.|
40mg/mL injectable – 10 mL per vial
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