Multistate outbreak of fungal meningitis and other infections

Update on NECC Products: Samples of injectable betamethasone, injectable triamcinolone and cardioplegia solution test positive for microbial contamination

[11-20-2012] **The chart is updated to include new culture results

[11-02-2012] *The chart is updated to include additional species of Bacillus bacteria.

[11-01-2012] The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are reporting laboratory results from samples of two additional recalled NECC products – preservative-free injectable betamethasone and cardioplegia solution. Previously, the fungus Exserohilum rostratum was identified in NECC-supplied, preservative-free methylprednisolone acetate (MPA).

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.

Medication	Lot number	Microbial contamination
Betamethasone 6 mg/mL injectable – 5 mL per vial	08202012@141	Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp., Bacillus niacin, * Koceria 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 6 mg/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	Fungal growth – identification pending
**Triamcinolone 40 mg/mL injectable – 1 mL per vial	06062012@6	Bacillus lentus, Bacillus circulans
**Triamcinolone 40 mg/mL injectable – 2 mL per vial	08172012@60	Fungal growth – identification pending
**Triamcinolone 40 mg/mL injectable – 10 mL per vial	08242012@2	Fungal growth – identification pending
Cardioplegia solution 265.5 mL per bag	09242012@55	*Bacillus halmapalus/horikoshii, Brevibacillus choshinensis

The clinical significance of these results is not known. Both Bacillus idriensis and Bacillus circulans have been rarely reported as a cause of human disease. CDC continues to investigate reports of potential infections in patients receiving other NECC products. As of Nov. 1, 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.

Although final laboratory results on additional samples are still pending, the findings of fungal contamination of MPA, injectable betamethasone, and injectable triamcinolone, and bacterial contamination of injectable betamethasone, injectable triamcinolone and cardioplegia solution reinforce the FDA’s concern about the lack of sterility in products produced at NECC’s compounding facility and serve to underscore that hospitals, clinics, and health care providers should not use any NECC-supplied products. All NECC products are subject to NECC’s recall announced on Oct. 6, 2012.

As previously confirmed by the CDC and FDA, the fungus Exserohilum rostratum was identified from 2 different lots of NECC-supplied, preservative-free MPA (Lot #06292012@26 and Lot #08102012@51), which have been associated with the outbreak of fungal meningitis and other infections in patients. Testing on the third implicated lot of MPA (Lot #05212012@68), as well as other NECC products, is ongoing.

Health care professionals and patients may call the FDA's Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the Ameridose recall and speak directly to a pharmacist.

The FDA asks health care professionals and consumers to report any adverse reactions to the FDA's MedWatch Program by fax at 800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch¹.