The recalled product is the Hudson RCI Addipak, unit dose vials, 5 milliliters sterile 0.9% NaCl solution for inhalation. The units were “dispositioned for scrap” but were accidentally distributed. It is unclear why the vials did not meet sterility standards.
The FDA labeled the recall as Class I, the most serious type of notice, because use of the product could result in serious injury or death. Customers were warned about the recall in early August, according to the database.
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