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Xactdose albuterol solution repackaging not validated to ensure product is organism free, FDA-483 charges.

Executive Summary

XACTDOSE INHALATION PRODUCT REPACKING VALIDATION CITED IN FDA-483 inspection report as inadequate. FDA issued the report following an April 17-30 inspection of the South Beloit, Ill. repacking firm. Xactdose issued a Class I recall of several lots of its albuterol sulfate solution for inhalation unit-dose product on May 31 for possible bacterial contamination ("The Pink Sheet" June 3, T&G-19).
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PS028328

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