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  1. Drug Safety and Availability

Multistate outbreak of fungal meningitis and other infections

fungal meningitis

Laboratory Testing and Results

[12-12-2012] FDA and CDC have identified bacterial and/or fungal contamination in unopened vials of betamethasone, cardioplegia, and triamcinolone solutions distributed and recalled from NECC. These include bacteria known as Bacillus, and fungal species including Aspergillus tubingensis,  Aspergillus fumigatus,  Cladosporium species,and Penicillium species.  Although rare, some of the identified Bacillus species can be human pathogens.  Some of the fungal organisms identified, particularly Aspergillus fumigatus, are known to cause disease in humans.  It is not known how product contamination with these organisms could affect patients clinically.  See CDC’s Advice for Clinicians.

CDC and FDA Laboratory-Confirmed Organisms from Product Samples

Laboratory-Confirmed Organisms from Product Samples Associated with
NECC Recalled Lots of Betamethasone, Cardioplegia, and Triamcinolone Solutions

Medication Lot Number Bacterial and Fungal Contamination
Betamethasone
6 mg/mL injectable –5 mL per vial
08202012@141 Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp., Bacillus niacini, Kocuria rosea,
Bacillus lentus
Betamethasone
6 mg/mL injectable –5 mL per vial
07032012@22 Bacillus niabensis, Bacillus circulans
Betamethasone
12 mg/mL injectable – 5 mL per vial
07302012@52 Bacillus lentus, Bacillus circulans, Bacillus niabensis, Paenibacillus barengoltzii/timonensis
Betamethasone
6mg/mL injectable – 5 mL per vial
08202012@44 Bacillus lentus, Bacillus firmus, Bacillus pumilus
Betamethasone
6 mg/mL injectable – 5 mL per vial
08152012@84 Penicillium sp., Cladosporium sp.

Triamcinolone
40mg/mL injectable – 1 mL per vial
06062012@6 Bacillus lentus, Bacillus circulans, Bacillus niabensis, Bacillus nealsonii, Bacillus subtilis group, Bacillus firmus
Triamcinolone
40 mg/mL injectable – 2 mL per vial
08172012@60 Aspergillus tubingensis, Penicillium sp.
Triamcinolone
40mg/mL injectable – 10 mL per vial
08242012@2 Aspergillus fumigatus
Cardioplegia solution
265.5 mL per bag
09242012@55 Bacillus halmapalus/horikoshii, Brevibacillus choshinensis

 

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