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Public Health Advisory:
Contamination of Multi-dose Bottles of Albuterol Sulfate Solution for
Inhalation (0.5%)
Issue: Contamination of Multi-dose Bottles of
Albuterol Sulfate Solution for Inhalation (0.5%)
The Agency has become aware of two recent hospital
outbreaks of lower respiratory tract colonization and infection with Burkholderia
cepacia attributed to contaminated multi-dose bottles of albuterol
sulfate. In addition to these recent outbreaks, there have been several
previous outbreaks reported in the medical literature. In most cases,
colonization or infection occurred in the ICU setting, often in patients
receiving mechanical ventilation. In the recent outbreaks, the adverse
outcomes attributable to the respiratory tract infections with B. cepacia
include prolonged hospitalization, pleural space infection, complications
of antibiotic use, and death. Investigations revealed that the source of
the exposure was contamination of bottles of multi-dose albuterol sulfate
solution, likely due to failure to adhere to good, aseptic technique on
the part of the respiratory therapists administering the medication.
Additionally, it appears that the practice of using a single bottle for
multiple patients over time contributed to the outbreak. Institution of
more aggressive infection control training and procedures resulted in a
marked reduction in the incidence of these infections.
The medical community, particularly respiratory
therapists and ICU staff, is reminded to pay careful attention to proper
aseptic technique each time a multi-dose bottle for nebulization is opened
and used. Specifically, precautions should be taken to prevent contact of
the dropper tip with any surface, including the nebulizer reservoir and
associated ventilatory equipment. These instructions are currently
included in the product label and the "Patient's Instructions for
Use" document provided with the drug product. Additional measures
that may be important in reducing the risk of contamination and subsequent
outbreaks of infections include avoiding the use of a single bottle for
more than one patient, and using a single-use container to dilute the
solution prior to placing it in the nebulizer reservoir.
Albuterol sulfate solution for inhalation 0.5% is
supplied in 20mL multi-dose glass bottles with accompanying calibrated
dropper. Prior to administration, each 0.5mL dose is diluted with 2.5mL of
sterile isotonic saline in the nebulizer reservoir. Each bottle can
deliver up to 40 doses of albuterol sulfate. Two approaches have been
taken in order to avoid microbial contamination of the contents of the
bottle once opened. First, the formulation contains the preservative
benzalkonium chloride. Second, the product label instructs users to follow
aseptic technique when administering the drug. Specifically, the label
states that precautions should be taken to prevent contact of the dropper
tip of the bottle with any surface.
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FDA/Center for Drug Evaluation and Research
Last Updated: April 19, 2002
Originator: OTCOM/DLIS
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