Bacillus and other Bacateria Found in NECC Betamethasone and Cardioplegia Solution

The FDA and CDC have found bacteria in two additional products recalled recalled by New England Compounding Center (NECC), a compounding pharmacy:

  • preservative-free injectable betamethasone and
  • cardioplegia solution.

Previously, the fungus Exserohilum rostratum was identified in NECC-supplied, preservative-free methylprednisolone acetate (MPA), which has been linked to over 400 cases of spinal meningitis, both Aspergillus and Exserohilum meningitis.

The FDA and CDC laboratories have identified bacteria present in three separate lots (batches) of NECC-supplied preservative-free injectable betamethasone, with each lot producing different culture results, and in a single lot of NECC cardioplegia solution.

  • Betamethasone 6 mg/mL injectable – 5 mL per via –
    • LOT#08202012@141
    • MICROBIAL CONTAMINATION: Paenibacilluspabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp., *Bacillus niacini
  • Betamethasone 6 mg/mL injectable – 5 mL per vial
    • LOT#07032012@22
    • MICROBIAL CONTAMINATION: Bacillus niabensis, Bacillus circulans
  • Betamethasone 12 mg/mL injectable – 5 mL per vial
    • LOT#07302012@52
    •  Bacillus lentus, Bacillus circulans, *Bacillus niabensis, Paenibacillus barengoltzii/timonensis
  • Cardioplegia solution – 265.5 mL per bag
    • LOT #09242012@55
    • MICROBIAL CONTAMINATION:*Bacillus halmapalus/horikoshii, Brevibacillus choshinensis

Fungal cultures for injectable betamethasone and cardioplegia solution are pending and the presence of additional microbial organisms and/or fungus in these products cannot be ruled out at this time.CDC continues to investigate reports of potential infections in patients receiving other NECC products. CDC has not received reports of laboratory-confirmed cases of infection due to Bacillus or closely related organisms linked to betamethasone or cardioplegia solution from NECC.


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Category: Product Liability
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