Bacterial Contamination in NECC Betamethasone and Cardioplegia Solution

The FDA has found bacterial contamination in two additional drugs made by New England Compounding Center (NECC). According to the FDA:

Laboratory results from samples of two additional recalled NECC products – preservative free betamethasone and cardioplegia solution – have tested positive for bacterial contamination. FDA and CDC laboratories have identified bacteria present in three separate lots (batches) of NECC-supplied preservative-free betamethasone, with each lot producing different culture results, and in a single lot of NECC cardioplegia solution.

CDC and FDA Laboratory-Confirmed Organisms from Product Samples of Betamethasone and Cardioplegia Solution

  • Betamethasone6 mg/mL injectable –5 mL per vial
    • LOT# 08202012@141
    • MICROBIAL CONTAMINATION: Paenibacillus pabuli/amolyticus; Bacillus idriensis; Bacillus flexus; Bacillus simplex; Lysinibacillus sp., Bacillus niacini
  • Betamethasone6 mg/mL injectable –5 mL per vial
    • LOT# 07032012@22
    • MICROBIAL CONTAMINATION: Bacillus niabensis; Bacillus circulans
  • Betamethasone12 mg/mL injectable – 5 mL per vial
    • LOT# 07302012@52
    • MICROBIAL CONTAMINATION: Bacillus lentus, Bacillus circulans, Bacillus niabensis, Paenibacillus barengoltzii/timonensis
  • Cardioplegia solution265.5 mL per bag
    • LOT# 09242012@55
    • MICROBIAL CONTAMINATION: Bacillus halmapalus/horikoshii, Brevibacillus choshinensis

The FDA has also identified a patient with possible meningitis potentially associated with epidural injection of an additional NECC product, triamcinolone acetonide, a type of steroid injectable product.Methylprednisolone acetate made by NECC has been linked to over 380 cases of meningitis in 19 states.

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Category: Medical Products And Procedures
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