Table 2.

Description of the drugs, compounding pharmacies, and findings from the outbreak investigation

#	Drug name and route	Source – pharmacy name and location	Lots involved and scope of recall	Factors contributing to outbreak	Re f
1	Betamethason e suspension for epidural, conjunctival, or intra- articular injection	Doc’s Pharmacy; Walnut Grove, CA	1 lot of 60 vials (5 mL per vial). 35 of 51 recovered vials grew Serratia marcescens. State of California forced recall of all ophthalmic and injectable drugs made by the pharmacy.	Pharmacy technician omitted final autoclaving step for a single lot on a single day. California State Board of Pharmacy found improper segregation of sterile compounding area, inadequate staff training and supervision, and poor labeling practices. S marcescens cultured on compounding equipment. Information about outbreak was not found on FDA Web site.	45, 58
2	Methylpredni solone suspension for epidural injection	Urgent Care Pharmacy; Spartanburg, SC	Estimated 1000 vials dispensed from Feb to July 2002. Exophiala dermatitidis cultured from unopened vials in 3 lots. All products from the company recalled because sterility could not be assured.	South Carolina Board of Pharmacy found improper autoclave performance, no sterility testing, inadequate clean-room practices.	42, 46,59
3	Heparin- vancomycin IV flush	Pharmacy name unknown, FL	1 lot of approximately 35 flush solutions made specifically for 2 patients. Burkholderia cepacia cultured in 1 of 21 flushes for patient 1 and 1 of 14 flushes for patient 2.	Source of B. cepacia contamination in pharmacy not identified. FDA inspection did not identify specific deficiencies. Information about outbreak was not found on FDA Web site.	47
4	Magnesium sulfate IV injection	PharMEDium Services LLC; Houston, TX	240 units per lot (50 mL admixtures). S marcescens cultured from 3 of 20 units from lot A which was shipped to 5 hospitals in 5 states. Patients in CA received drug from another lot, but no samples available for testing. After multiple Gram-negative organisms cultured from units in an additional lot, company recalled all magnesium sulfate lots and stopped making the product.	A definitive source of contamination was not found, but manipulation of small admixture bags by compounding pharmacist was suspected source. Samples from each lot of were not retained or tested for sterility. FDA inspection of facilities in several states found problems with environmental monitoring, product labeling, and quality assurance processes.	32, 48
5	Heparin- saline IV flush	IV Flush, Rowlett TX.	Number of doses and lots unclear. 7 of 9 lots of unopened prefilled syringes grew Pseudomonas fluorescens. Product distributed to facilities in up to 17 states in the year before outbreak detection. There was a nationwide Class I recall of this product.	IV Flush contracted with a compounding pharmacy to make concentrated heparin solution that IV Flush then diluted and repackaged into syringes. CDC determined contamination occurred at IV Flush. Sterility testing was not performed for concentrated heparin solution or finished product. Contamination of raw material was unlikely. FDA inspection found global quality assurance and production problems.	22, 49, 50 60, 61
6	Trypan blue 0.06% ophthalmic solution	Custom RX Compounding Pharmacy; Richfield, MN	2 lots of 50 syringes each. Pseudomonas aeruginosa cultured from 12 syringes and B cepacia from 4 syringes in these lots. Recall involved 5 lots of trypan blue.	Source of contamination in compounding pharmacy was not identified. Details of the FDA investigation could not be located.	25, 62
7	Cardioplegia solution	Central Admixture Pharmacy Services, Inc.; Lanham, MD.	Gram-negative bacilli and endotoxin found in 2 lots of cardioplegia. Outbreak led to recall of all of the company’s sterile compounding products.	Compounding pharmacy was the only likely source of contamination. FDA inspection at 4 facilities found multiple deficiencies including inadequate environmental monitoring, training of personnel, and quality assurance, and failure to maintain equipment.	51, 52, 63 64
8	Fentanyl 10 mcg/mL in 250 mL normal saline for IV injection	Illinois*	16 of 26 unopened IV bags from implicated lot grew Spingomonas paucimobilis; 9 samples from 3 other lots produced no growth. No product was recalled.	Evidence strongly suggests the compounding pharmacy was the source of outbreak. Information about outbreak was not found on FDA Web site.	53 *
9	Total parenteral nutrition for IV injection	Meds IV Pharmacy; Birmingham, AL	Number of doses and lots unknown. Company recalled all IV compounded products.	Alabama Dept of Public Health found deficiencies in mixing, filtration, and sterility testing. S marcescens contamination likely came from water faucet that was used to clean a container in which TPN was mixed.	54, 55
1 0	Bevacizumab intravitreal injection (preservative free)	Infupharma, Hollywood, FL	2 single-use vials of Avastin (bevacizumab) repackaged into 65 syringes (0.1 mL each) in 4 lots. Streptococcus mitis/oralis cultured from 7 unused syringes. FDA found microbial growth in 3 of 21 syringes in 2 additional lots of bevacizumab.	The most likely cause of this outbreak was contamination during syringe preparation by the compounding pharmacy. FDA found single-use vials had been used for days to weeks after initial vial puncture, inadequate environmental monitoring, use of non- sterile materials, inadequate personnel training, and other deficiencies.	26, 56, 57 65, 66
1 1	Brilliant Blue-G (preservative free)	Franck’s Compounding Laboratory; Ocala, FL	4 lots recalled; multiple bacterial and fungal species, including Fusarium incarnatium-equesteti, cultured from unused syringes.	FDA found bacterial and fungal growth in ISO Class 5 laminar flow hoods and ISO Class 7 clean room. Deficiencies included inadequate personnel training, environmental monitoring, and sealing of clean room.	21, 67 68
	Triamcinolon e intravitreal injection (preservative free)		2 lots of triamcinolone acetonide 80 mg/mL recalled; 8 prescriptions in 1 lot and 5 in the other. Microbial testing ongoing. Company recalled all sterile compounded products.
1 2	Methylpredni solone acetate (MPA) suspension for epidural or intra-articular injection (preservative free)	New England Compounding Center, Framingham, MA	Initial recall involved 17,676 vials from 3 lots of MPA 80 mg/mL. Unopened vials in 2 lots were contaminated with E rostratum. Testing of third lot is ongoing. After inspection of facility found that sterility could not be ensured, all products from NECC and sister company, Ameri-dose, were recalled. Three clinics in TN used 1663, 189, and 211 vials of MP during outbreak. In this case cluster, attack rate varied by lot involved and age of lot.	FDA inspection found multiple deficiencies, including bacteria and mold in clean rooms used for sterile compounding, standing water near the clean room, airborne particulates resulting from close proximity to recycling facility. Investigation is ongoing.	27, 69, 70 71

^*L. Maragakis, MD, e-mail communication, December 15, 2012